Title of Invention

FOOD PRODUCTS FOR DIABETICS

Abstract

Disclosed is a novel food product characterized by a low glucose or glucose free content, a balanced functional fat content, and a proactive agent aimed for the diabetic and diabetic-prone populations. The food product of the invention is a functional food which may be used clinically to lower the lipid level in people suffering from an imbalanced lipid profile and which may progress towards diabetes complications and coronary vascular disorders. In particular embodiments the proactive agent can be any of a naturally occurring lipid, a synthetic or mimetic lipid which is not digestible by humans and interferes with body weight gain/loss, plant extracts and substances derived therefrom, antioxidants, animal-derived substances, minerals and Pharmaceuticals, and any mixture thereof.

Full Text

Field of the Invention The present invention relates to the field of functional fds and clinical fds. More specifically, the present invention provides novel fd products with a balanced and functional fat content, aimed for the diabetic and diabetic-prone populations. Background of the Invention All publications mentioned throughout this application are fully incorporated herein by reference, including all references cited therein. Diabetes mellitus Type 2, is a multiple aetiology metabolic disorder, characterized by chronic hyperglycemia with disturbances of carbohydrate, fat and protein metabolism, resulting from a partial or absolute deficiency of insulin. A deficiency of insulin in the body results in diabetes mellitus. Diabetes is a common disease and according to the Center for Disease Control and Prevention (CDC) survey in 22, 6.3% of the American population suffers from diabetes (21.1% out of the adult population). About 1.3 million new cases (aged above 2 years) are reported each year and it is estimated that only about half the people who currently have diabetes are diagnosed. The effects of diabetes mellitus include long-term damage, dysfunction and failure of various organs. Often, diabetes symptoms are not as severe; however long-term hyperglycemia results in cardiovascular disease (CVD, see below), retinopathy (blindness), nephropathy (renal failure) and/or neuropathy (ft ulcers, amputation etc.). Accelerated decline of cognitive function and other brain functions or tissues damage is often induced by or accompanied to diabetes mellitus. The metabolic abnormalities in Type 2 diabetes mellitus, which result from primarily insulin resistance in liver, muscle, and adipose tissues, lead to an increase in the bled sugar and hyperinsulinemia (high insulin bled level). Insulin resistance also leads to a disturbance of virtually all the regular cardiovascular-associated risk factors, bled pressure and lipoproteins in particular, which will increase atherosclerosis (a process based on fat metabolism abnormality) incidence. The high insulin levels seen in insulin resistance may also directly promote the development of atherosclerosis. Accumulation of fat in the abdominal area, particularly in the visceral fat compartment, is associated with the development of insulin resistance and increased risk to display complications such as diabetes mellitus. The relationship between fatty acid content of triglyceride (TAG), visceral adipose tissue accumulation, and metabolic components of the insulin resistance syndrome have been extensively investigated [Tremblay, A. J. et al. (24) Metabolism 53, 31-317]. The adipose tissue is not simply an energy storage organ but also a secretory organ. The regulatory substances produced by adipocytes, which include leptin, resistin, and adiponectin, may contribute to the development of insulin resistance. Furthermore, the elevated level of free fatty acids occurring in obesity, had been implicated in the development of insulin resistance [Grundy SM. (24) J Clin Endocrinol Metab, 89(6):2595-26]> Diabetes patients are three to five times more likely to have coronary heart disease (CHD) and stroke than non-diabetic patients. In fact, heart disease is the leading cause of diabetes-related deaths. Numerous studies have shown that oxidative stress may also play a major pathophysiological link between CVD and Type 2 diabetes [Baynes J. W. and Thorpe S. R. (1999) Diabetes 48:1-9]. Oxidative stress, a relative increase in free radicals, is a direct consequence of hyperglycemia. Reactive oxygen molecules created by this metabolic imbalance activate monocytes and maerophages triggering the proliferation of vascular smth muscle cells and an overall diabetic angiopathy. One of the main outcomes of this process is the generation of high levels of oxidized-LDL species, which are taken in by maerophages through scavenger receptors (and not native LDL receptors), to give rise to foam cells, the hallmark of early atherosclerosis [Griendling, K.K. and FitzGerald, GA (23) Circulation 18(17): 234-4]. The dysh'pidemia associated with insulin resistance and Type 2 diabetes is characterized by elevated triglycerides, low levels of HDL cholesterol, an increase in the proportion of small, dense, and potentially more atherogenic LDL cholesterol particles. These abnormalities are present for years before diabetes mellitus is diagnosed clinically. Elevated triglyceride levels, reduced HDL cholesterol, and increased atherogenic LDL cholesterol levels are all risk factors forCVD. Several population based studies have shown that Type 2 diabetes also increases the risk of dementia. Cognitive decline is an intermediate stage between normal ageing and dementia. As dementia may be most effectively delayed in its initial stages, identifying diabetes as a modifiable risk factor for early cognitive decline could be of major importance. Eecently, a large study focused on elderly women with Type 2 diabetes described increased odds of pr cognitive function and substantial cognitive decline in these patients, compared with women without diabetes [Logroscmo et al, (24) BMJ. 328:548-553]. Fatty acid differences, including docosahexaenoic acid (DHA) have been shown in the brains of Alzheimer's disease (AD) patients as compared with normal agematched individuals. Furthermore, low serum DHA is a significant risk factor for the development of AD. It was recently argued by Muskiet and colleagues [Muskiet F.A, et al. (24) J Nutr. 134:183-6] that DHA is in fact an essential fatty acid, also in light of its relation to cognitive functions. Indeed, other investigators stated that dietary intake of omega-3 fatty acids and weekly consumption offish may reduce the risk of incident Alzheimer's disease. Diabetes impairs essential fatty acid metabolism by decreasing activities of A6 and A5 desaturases, enzymes that convert dietary linoleic acid and alphalinolenic acid to long-chain polyunsaturated fatty acids (PUPA), including gamma-linolenic acid, arachidonic acid (AA), eicosapentaenoic acid (EPA), and DHA. As a result, AA and DHA levels are reduced in membrane phospholipids of several tissues, including erythrocyte and sciatic nerve. It was demonstrated recently that dietary supplementation with fish oil, containing EPA and DHA, partially prevented the diabetes-induced decrease in nerve conduction velocity, a physiological marker of diabetic neuropathy. This was further correlated hi a recent report that presented evidence for a marked neuro-protective effect of DHA on diabetic neuropathy. Furthermore, there are several reports describing the beneficial effects of fish oil-derived omega-3 fatty acids supplementation on serum triglycerides, HDL, lipid peroxidation and antioxidant enzymes, which may lead to decreased rate of occurrence of vascular complications and minimize the cognitive decline in diabetes. The importance of prevention of diabetes in high-risk individuals is highlighted by the substantial and worldwide increase in the prevalence of diabetes in recent years. Genetic susceptibility appears to play a powerful role in the occurrence of Type 2 diabetes in certain populations. However, given that population gene pls shift quite slowly, the current epidemic likely reflects marked changes in lifestyle that are characterized by decreased physical activity and increased energy consumption. Weight reduction, exercise, and dietary modifications often correct the hyperglycemia of Type 2 diabetes. Therefore, changes in the population habits, including nutrition habits, may decrease the risk of developing diabetes and diabetes complications. Diabetes patients are first of all treated, mostly through medication, in regard to their hyperglycemia and glucose control. This is aimed to prevent long-term complications. As mentioned above, the long-standing elevation of bld glucose causes chronic complications of diabetes-premature atherosclerosis, retinopathy, nephropathy, and neuropathy. In some cases their cardiovascular health is addressed, again mainly through medications, in regard to their hyperlipidemia, mainly hypercholesterolemia. little or no treatment is provided for their hypertriglyceridemia. An important risk factor, associated and even induced with their metabolic disorder is bld oxidative stress. This risk factor leads to atherosclerosis, and together with hyperlipidemia, it is one of the main causes of mortality of cardiovascular disorders among diabetes patients. Diabetic patients are recommended to modify nutrient intake and lifestyle as appropriate for the prevention and treatment of obesity, dyslipidemia, cardiovascular disease, hypertension, and nephropathy. The American Diabetes Association has recently published goals of medical nutrition therapy aimed to attain optimal metabolic outcomes including bld glucose, lipid profile and bld pressure in order to prevent and treat the chronic complications of diabetes [Franz MJ, Et al, Diabetes Care 25:148-198, 22; American Diabetes Association Position Statements "Nutrition Principles and Recommendations in Diabetes " (24]. Nevertheless, diabetics are typically treated only in regard to glucose control and their hyperglycemia through strict diets. These diets are mainly designed to lower the amount of dietary glucose to a minimum. In most cases, these diets are not designed to promote heart health, let alone fight the main cardiovascular risk factors. Diabetes patients are offered unique fd products, especially designed to accommodate their unique dietary requirements in regard to minimal glucose levels. However, in most cases, these fd products are rich in lipids, and especially triglycerides, in the form of oils and fats. These fats are added in order to compensate the lack of glucose and the pr sensorial properties of the resulting fds. Although this addition indeed yields sensorial desirable fd articles, they have severe adverse effects on the diabetes patients who should fear fat-rich products almost as much as glucose-rich products. Furthermore, due to fd technology reasons, many of the fats and oils used in fd products for diabetics are actually saturated fats which enhance even more the risk of the acute cardiovascular disorders of diabetics. Moreover, in many cases, fd products for diabetics consist of higher levels of fats than their counterpart, "regular" fd products. This difference in fat levels can reach up to 6% additional fats in diabetics' specialty fds. Therefore, there is a great need in the market for specialised fd aimed at the diabetic population, in which all its content, and not only the glucose component, will be beneficial for said population. It is important to provide diabetics, or individuals prone to diabetes, with fds wherein the fat content is appropriate for their needs. Said specialized fd products shall be fat balanced, and its fat content shall even be beneficial to diabetics or people prone to diabetes. Furthermore, it will be beneficial if diabetics will be able to consume through their specialized daily nutrition additional ingredients that may have a protecting health effect and even a pro-active beneficial health effect, especially on their cardiovascular condition and/or on different risk factors leading to the development or progress of CVD. Thus, it is an object of the present invention to provide a fd product or article with low glucose levels or glucose free and a balanced lipid profile, this fd also comprising at least one diabetes-proactive dietary or pharmaceutical substance, it does not contain significantly high levels of fats and oils and, most importantly, comprises minimal amounts of saturated fats, substantially lower than the amounts currently used in diabetics fds available on the market. Other uses and objects of the invention will become clear as the description proceeds. Despite the understanding of nutrition and medical experts of the specific health needs of diabetics, especially their cardiovascular needs, and despite the progress in fd technology that may enable the use of healthier oils and fats and at smaller amounts, no one has yet combined the three (nutrition, medicine, fd technology) to yield fds such as presented by the inventors. Furthermore, no diabetic fd product has introduced a pro-active approach to address such cardiovascular needs. Although the cardiovascular health needs of diabetics are perhaps the most extreme, other populations can consume and benefit from the fd products of the invention. Such populations also include pre-diabetics which are prone or are at high risk of developing Type 2 diabetes and cardiovascular diseases. Prediabetics may be individuals with high risk to develop Type 2 diabetes in light of different conditions including genetic background, over-weight, obesity and especially abdominal obesity, specific ethnicity, previously identified as impaired fasting glucose (EPG) or impaired glucose tolerance (IGT), hypertension, dyslipidemia, history of gestational diabetes, as well as elderly individuals. Several of the risk factors may exist simultaneously, dramatically elevating the risk to develop a diabetic condition. Other populations that may benefit from the fd products of the invention are individuals diagnosed with the metabolic syndrome or Syndrome X, which is characterized by glucose intolerance, hyperinsulinaemia, dyslipidemia, hypertension, visceral obesity, hypercoagulability, and proinflammatory state. All the above mentioned symptoms define a cluster of CVD risk factors. Similarly, CVD patients, including patients who already suffered a cardiovascular event, as well as individuals which are at high risk or prone to develop CVD due to metabolic syndrome, obesity, over weight, hypertension, dyslipidemia, etc., may benefit. Other populations with different metabolic disorders may also benefit from the fd products of the invention since most metabolic disorders may lead to cardiovascular health problems and the subsequent adverse effects and symptoms. Health conscious populations who wish to consume balanced diets, especially from a fat content point of view, also having pro-active effects in the prevention or inhibition of CVD and metabolic » disorders, especially diabetes or diabetes-prone subjects may also benefit from the fd products of the invention. Recent studies have highlighted the potential for intervention in IGT subjects to reduce progression to Type 2 diabetes. For example, the Diabetes Prevention Program in the United States [The Diabetes Prevention Program (1999) Diabetes Care 22:623-634] had proved that lifestyle intervention (targeting diet and exercise) over a period of three years, reduced the risk of progressing from IGT to diabetes by 58%, whereas the oral hypoglycemic drug, metformin, reduced the risk by only 31% [Larkin, M. (21) Lancet. 358(9281):565]. Another large-scale study conducted by a Finnish diabetes prevention organization [Sarkkinen E. et aJ.,(1996) Eur J Clin Nutr 5(9):592-8] proved that non-pharmacological lifestyle intervention at people with high risk to develop type 2 diabetes prevents or at least postpones the onset of the disease. In other studies, it was shown that the approach aimed at high-risk individuals (for example, those with impaired glucose tolerance (IGT)) may not be sufficient in preventing all the cases of Type 2 diabetes. Data from the UKPDS indicate that pancreatic p-cell function is already substantially reduced at the time of clinical diagnosis of Type 2 diabetes [UK Prospective Diabetes Study (UKPDS) Group (1998) Lancet 352(9131):837-853; U.K. Prospective Diabetes Study Group (1995) Diabetes 44(11): 1249-1258]. Consequently, therapeutic interventions with hypoglycemic drugs or with functional/medical nutrition products should be considered for prevention as well. Current special fds for diabetics are also being consumed by populations merely seeking weight loss/control, not necessarily required from a medical or health risk point of view. These populations mistakenly interpret the no glucose/sugar labels of such products as being weight loss/control fds in the sense of low fat and/or low calorie. As mentioned above, most if not all currently available fd products designed and/or recommended for the diabetic population actually have higher levels of fat, and even saturated fats, as well as high caloric content. In many cases, such a specialized fd product has a higher fat content and/or caloric content than the corresponding "regular" fd product (see examples). Therefore, populations seeking weight loss/control fds, as described above, can also benefit from the fd products of the invention which have a balanced and even low fat content, lower levels of saturated and other unhealthy fats, as well as optionally including ingredients which can improve health, as described in the invention. Surprisingly, the fd products of the invention may also have a preventive effect in regard to the development of Type 2 diabetes. Consumption of the fd products, having said balanced fat content, low levels of glucose, and optionally at least one active ingredient can prevent or inhibit the onset of diabetes. A diet based on the fd products of the invention or rich with such fd products can control glucose metabolism and even insulin secretion. Consumption of such a diet can decrease the propagation of pancreatic P cells deterioration process and might even lead to a reduction or reversion of insulin resistance. Diets based on the fd products of the invention may stabilize the glycemic state, control the insulin secretion, and furthermore reduce the accumulation of visceral fat. Abdominal fat. accumulation is considered to be the underlying process accompanies the progression of Type 2 diabetes; therefore reduction of fat accumulation in the abdomen may prevent or postpone the diabetes onset and progression. Summary of the Invention In a first aspect, the present invention relates to a fd product or article characterized by having a low glucose content or being glucose free, a balanced fat content and comprising at least one dietary or pharmaceutical substance which is proactive towards diabetes and any of its complications, and/or towards a condition leading to diabetes, for addressing health needs of diabetics or for 1 preventing onset of diabetes in healthy individuals or individuals prone to diabetes. In said fd product the diabetes-proactive dietary or pharmaceutical substance may be any one of a naturally occurring lipid, a synthetic or mimetic lipid which is not digestible by humans and inhibits body weight gain, plant extracts and substances derived therefrom, antioxidants, animal-derived substances, minerals and Pharmaceuticals, and any mixture thereof, said substances being optionally dispersed or dissolved in an edible oil or fat. In a particular embodiment, the lipid in said fd product may be any one of diacylglycerols, particularly 1,3-diacylglycerols, phytosterols and phytosterol esters, phytostanols and phytostanol esters, polycosanols, omega-3 fatty acids and their derivatives, particularly long-chain polyunsaturated fatty acids (LCPUFA), polyunsaturated fatty acids (PUFA), particularly alpha-linolenic acid, and conjugated linolerae acid (CLA); and/or a non-digestible synthetic lipid or lipid mimetic is an alpha branched triglyceride or olestra, respectively. The plant extract or substance derived therefrom component in said fd product may be any one of garlic extract, soy protein, soy isoflavone, lycopene, lutein, zeaxanthin, vitamin C, vitamin E and other tocopherols, beta-carotene, polyphenols, particularly hydroxytyrosol, folic acid, vitamin B6 and vitamin B12; the antioxidant is any one of rosemary extract, lycopene, zeaxanthin, selenium, zinc, vitamin C, vitamin E and other tocopherols, coenzyme Qio, beta-carotene, polyphenols, particularly hydroxytyrosol; the animal-derived substance may be whey protein or a casein; the mineral is calcium, selenium or zinc; and said pharmaceutical component may be any one of statins, ezetimibe, a drug controlling lipids profile or other biomarker related to cardiovascular diseases. The fd product in the invention may comprise at least one diabetes-proactive substance, although it may also include any mixtures thereof, optionally dispersed or dissolved in an edible oil or fat. In a more particular embodiment, said diabetes-proactive dietar}' substance is a mixture of phytosterol and/or phytostanol ester(s) with l,3-diacylglyceride(s), optionally dispersed or dissolved in an edible oil or tat. In a special embodiment, said fd product may further comprise at least one pharmaceutical drug, particularly a drug which is proactive towards diabetes, any condition leading to diabetes or any diabetic complication. In one embodiment, the fd article of the invention is functional in the treatment and/or prevention of cardiovascular disease (CVD) and/or its risk factors hyperlipidemia, dyslipidemia, oxidative stress and atherosclerosis, particularly in diabetic or diabetes-prone individuals. In another embodiment said fd product is functional in the treatment and/or prevention of hyperlipidemia, dyslipidemia, oxidative stress and atherosclerosis, particularly in diabetic or diabetes-prone individuals. In a particular embodiment, the fd product of the invention is functional in at least one of the following: reducing the total cholesterol serum level, reducing the non-HDL cholesterol serum level, reducing the total cholesterol/HDL ratio and reducing triglycerides serum level in an overweight, and/or obese, and/or diabetic, and/or diabetic-prone subject In another particular embodiment, said fd product is functional in reducing the body weight, and/or inhibiting body weight gain, and/or reducing insulin resistance in an obese and/or in a subject with metabolic imbalances such as diabetes and/or an individual prone to diabetes or obesity. In a special embodiment, said fd product is also functional in remodeling body fat distribution, suppressing white adipose tissue (WAT) accumulation and reducing visceral fat accumulation in an obese and/or overweight subject and/or diabetic subject and/or pre-diabetic subject and/or an individual prone to diabetes or obesity. In a broad aspect, the fd product of the invention is functional in reducing the risk of life threatening long term diabetes complications and deterioration of quality of life in an obese and/or diabetic subject. In a particular case, said complications are from macrovascular, microvascular or neurological origin and it is selected from the group of retinopathy, nephropathy, diseases of the large vessels supplying the legs (lower extremity arterial disease), coronary heart or artery diseases, cerebrovascular diseases and disturbed neural function afflictions, decline of cognitive functions, or any other condition which may lead to blindness, end-stage kidney disease (ESRD) and amputations, myocardial infractions and stroke. In another aspect, the fd product of the invention is functional in ameliorating hyperinsulinemia in an insulin-resistant subject. In a particular case, said fd product is functional in ameliorating hyperinsulinemia or preventing progression of insulin resistance in an obese subject prone to develop diabetes. In a further embodiment, the fd product of the invention further comprises active agents which are functional in the prevention and/or treatment of acut§ cognitive decline and said active agent is any of phosphatidylserine, ginko biloba, brahmi (Bacopa monnieri) or omega-8 containing fats. In an additional embodiment, the fd product of the invention further comprises active agents which are functional in the prevention and/or treatment of acute ophthalmic conditions associated with Type 2 diabetes, wherein said active agents are vitamins, antioxidants, and other natural eye-health promoting ingredients or extracts. Finally, the fd product described herein may be one of dairy products, bakery products, condiments, beverages and drinks, snacks, candies, ice-creams and frozen desserts, morning cereals, nutrition bars, snack bars chocolate products. prepared fds, grain products and pasta, soups, sauces and dressings, confectionery products, oils and fats products, dairy and milk drinks, soy milk and soy dairy-like products, frozen fd products, prepared meals and meal replacements, meat products, cheeses, yoghurts, breads and rolls, yeast products, cakes and ckies and crackers. Brief Description of the Figures Figure 1: Plasma total cholesterol levels in diabetic Psammomys obesus fed with mono and polyunsaturated fatty acid nutritional diets Abbreviations: HSFA - 1:1 Highly enriched with saturated fatty acids; HMUFA oil highly enriched with monounaturated fatty acids; T. Choi • total cholesterol; mg/dL - milligram per deciliter. Figure 2: Plasma non-HDL cholesterol levels in diabetic Psammomys obesus fed with mono and polyunsaturated fatty acid nutritional diets Abbreviations: HSFA - 1:1 Highly enriched with saturated fatty acids; HMUFA oil highly enriched with monounaturated fatty acids; Non-HDL. Choi. - nonhigh density lipoprotein cholesterol; mg/dL - milligram per deciliter. Figure 3: Plasma total cholesterol/HDL ratio in diabetic Psammomys obesus fed with mono and polyunsaturated fatty acid nutritional diets Abbreviations: HSFA- 1:1 Highly enriched with saturated fatty acids; HMUFA oil highly enriched with monounaturated fatty acids; T. Choi. - total cholesterol; HDL - high density lipoprotein cholesterol; Bat. - ratio; mg/dL milligram per deciliter. Figure 4: Plasma total cholesterol levels in "pre-diabetic Psammomys obesus fed with monounsaturated fatty acids nutritional diet Abbreviations: ILE. - High energy; T. ChoL - total cholesterol; mg/dL - milligram per deciliter. Figure 5: Plasma non-HDL cholesterol levels in "pre-diabetic" Psammomys obesus fed with monounsaturated fatty acids nutritional diet Abbreviations: H.E. - High energy; Non-HDL. Choi. - non-high density lipoprotein cholesterol; mg/dL - milligram per deciliter. Figure 6: Plasma total cholesterol/HDL ratio in "pre-diabetic" Psammomys obesus fed with monounsaturated fatty acids nutritional diet Abbreviations: H.E. - High energy; T. Choi. - total cholesterol; HDL - high density lipoprotein cholesterol; Rat. -ratio; mg/dL - milligram per deciliter. i Figure 7: Body weight of "pre-diabetic" Psammomys obesus fed with monounsaturated fatty acids nutritional diet Abbreviations: H.E. - High energy; E.P.B.W. - endpoint body weight; g - grams. Figure 8t Epididymal fat weight of "pre-diabetic Psammomys obesus fed with monounsaturated fatty acids nutritional diet Abbreviations: H.E. - High energy; E.P.E J1. - endpoint epididymal fat weight; g • grams. Figure 9: Epididymal fat/liver weight ratio of "pre-diabetic" Psammomys obesus fed with monounsaturated fatty acids nutritional diet Abbreviations: H.E. - High energy; E.F.W. - epididymal fat weight; Liv. W. - liver weight; Rat. - ratio; % • percentage. Figure 1: Plasma insulin levels in "pre-diabetic"Psammomys obesus fed with monounsaturated fatty acids nutritional diet Abbreviations: H.E. - High energy; Ins, - insulin; micU/ml - micro unit per milliliter. Figure 11: Plasma insulin levels relative to body weight in "pre-diabetic" Psammornys obesus fed with monounsaturated fatty acids nutritional diet Abbreviations: H.E - High energy; Ins. - insulin; B.W. - body weight; g - grams; micU/ml • micro unit per milliliter, Figure 12: Plasma insulin levels relative to plasma glucose levels in "prediabetic" Psammomys obesus fed with monounsaturated fatty acids nutritional diet Abbreviations: H.E. - High energy; Ins. - insulin; Glu, - glucose; mg/dL - milligram per deciliter; micU/ml - micro unit per milliliter. Detailed Description of the Invention In view of the pressing demand of the diabetic and diabetic-prone populations for specialized fd articles which are truly appropriate for their needs, as well as fin- health solutions addressing their unattended health risk factors, the present inventors have developed a novel fd product platform. Thus, in a first aspect, the present invention relates to a fd product or article, which has a low glucose content or is preferably glucose free, characterized in that its fat content is balanced, based on small amounts of non saturated oils and fats, and that it comprises at least one diabetes-proactive dietary or pharmaceutical substance for addressing health needs of diabetics, including, conditions leading to diabetes and diabetic complications, or for preventing onset of diabetes in healthy individuals or individuals prone to diabetes. A "diabetes-proactive dietary substance" as used herein, is any nutritional or dietary substance which can be consumed on a daily basis, provided as a day-today fd supply, without having any adverse effect that may compromise the health condition of a diabetic individual, aggravate or induce any risk condition related to diabetes, and does not promote the onset of diabetes in diabetic prone individuals, and this term also encompasses Pharmaceuticals and drugs. The "diabetes-proactive dietary product" is characterized by having low or no glucose content, a balanced fat content, preferably low levels of saturated fats or any other harmful fats, such as trans fats, together with the proactive ingredient. The proactive health benefit is achieved by being capable of improving or preventing dyslipidemia, hypertriglyceridemia, hypercholesterolemia, oxidative stress, high insulin bld levels, abdominal obesity, or other risk factors related to CYD, usually present in diabetic and diabetes-prone individuals. In a preferred embodiment the diabetes-proactive dietary substance is a mixture of phytosterol and/or phytostanol ester(s) (PS-E) with l,3-diglyceride(s) (DAG), optionally dispersed or dissolved in an edible oil or fat. Some favored mixtures may combine PS-E(s) and DAG(s), preferably with a higher phytosterols esters content relatively to DAG. Furthermore, said fd product may contain pharmaceutical active ingredients for addressing health needs of diabetics or for preventing onset of diabetes in healthy individuals or individuals prone to diabetes. In a preferred embodiment said pharmaceutical active ingredient aims to lower cardiovascular risk factors, such as dyslipidemia and/or abnormal lipid profile (for example high cholesterol bld level), frequent in diabetics or diabetic-prone individuals. Some of the preferred pharmaceutical active ingredients may include, but are not restricted to, statins, bile acid sequestrants and ezetimibe, which are effective in lowering LDL amounts by inhibiting cholesterol biosynthesis, preventing re-absorption of bile acids or by preventing absorption of dietary and biliary cholesterol together. Any other drug capable of controlling the lipids profile or other biomarker associated with cardiovascular diseases may be considered. The fd product of the invention contains at least one dietary active ingredient and/or at least one pharmaceutically active ingredient which may confer an additive health benefit or alternatively a synergistic health benefit. Basically, the market and producers of special fds for diabetics concentrate on fd products which are traditionally rich in sugar or sweet fds, such as candies, chocolate, ckies, fruit jams, cakes, etc. In these products the emphasis is on taking out the sugar without taking out the sensorial quality the consumer expects from such indulgence fds. This again emphasizes how the impact of nutrition on the diabetics1 health needs, especially those needs which are not directly related to their insulin resistance is basically overlked and/or ignored. Thus, it is the purpose of this invention to relate to the full scope of fd products consumed by individuals and making them more appropriate to consumption by diabetics or diabetes-prone individuals. In a specific embodiment the invention relates to fd products which are traditionally produced with high levels of fat, and especially saturated fat, and do not contain any proactive ingredients to address the CVD risk factors of diabetics, some of which are thriving because of pr nutrition. It should be emphasized that many fd products nowadays are indeed designed with low fat content and even with low caloric values with the aid of non-sugar carbohydrates, artificial sweeteners, and other fd additives, in response to the demand for fd products that would not contribute to weight gain and obesity. Nevertheless, these usually have a high percentage of saturated fat from the total fat content of the fd product and additionally they do not proactively contribute to the various health risk factors related to diabetics or which are more pronounced in diabetes patients or which are more crucial to pre-diabetics. By low glucose content as used herein is meant a glucose content of between up to 6% glucose, preferably from up to .5%, most preferably below .1%. By balanced fat content as used herein is meant is meant a fat or oil content of less than about 1%. Generally, the fat content of the fd product will, be similar or preferably lower than the fat content found in the corresponding fd product, which is not special for the diabetic or pre-diabetic population. Furthermore, the fat content should be comprised of little or no saturated fats, preferably less than about 25% of the total fat, more preferably below 1%. Moreover, the fat component of the diet may particularly comprise monounsaturated or polyunsaturated fatty acids, preferably more than about 2%, more preferably above 3%, even more preferably, above 4% of the total fatty acid moieties. Most importantly, the lipid profiles of the fd article of the invention consist of minimal amounts of saturated fats, and certainly considerably lower than the amounts currently used in fd articles for diabetics, which are, for example, up to 5, and even up to 75% of the total fat. This can be achieved through modern fd technology methodologies and additives that enable to reduce the levels of saturated fats, usually needed from technical or texture reasons. The fd products of the invention may include a variety of dietary active ingredients. Preferably, said ingredients contribute health benefits related to cardiovascular health or addressing risk factors of CVD in general, are also considered functionally active in the treatment and/or prevention of CVD in diabetic or diabetic-prone individuals. Phytosterol and/or phytostanols are phyto-derivatives of cholesterol clinically demonstrated to reduce bld cholesterol levels. Although they are structurally similar to cholesterol, they are not synthesized by the human body; they are very prly absorbed by the human intestine and tend to decrease the absorption of both dietary and endogenously derived cholesterol in the intestine. Phytosterols and/or phytostanols also include a variety of derivatives, such as fatty acid esters, as well as other ester derivatives. These ingredients have been shown to confer their health benefits at different daily intake levels. Current recommendations regarding the supplementation of phytosterols or their derivatives state an intake of ,8g of phytosterols, and higher levels of the stanol derivatives. Intake levels of different sterol derivatives are calculated accordingly. Phytosterols and/or phytostanols are generally produced from soybean or wd and other sources are available [Law M. (2) BMJ 32;861- Diglycerides (DAG) are mono-hydrolyzed derivatives of triglycerides, also known as oils and fats. DAG, mainly 1,3-diglycerides, as compared to TAG, have been previously shown to lower fasting and postprandial serum TAG concentrations in humans and in animal model. When consumed in large amounts, DAG lowers body weight, total fat and abdominal fat stores. Therefore consumption of DAG should be considered for treating obesity [Tada, N. (24) Curr Opin Clin Nutr Metab Care 7, 145-149]. DAGs have been marketed as fd products only as cking oil and certainly were not used in the nutrition of diabetics. DAG have been shown to conifer their health benefits mainly in cases where they were used to replace most or all of the daily dietary fat intake of individuals. In most cases, levels above lOg/day and even higher than 4g/day were used. Much lower levels of DAG have been shown to confer different CVD related benefits in specific combinations with fatty acid esters of phytosterols (see below). The fd products of the invention may indeed utilize DAGs to replace part of their fat content and even up to replacing the whole fat fraction, Specific phytosterol esters and DAGs combinations optionally dissolved or dispersed in oils and/or fats, and their attributes have been described in detail in co-pending co-owned WO 1/7583 and WO 3/6444 In brief, these formulations comprise a combination of DAG, mainly l,3-DAG(s) and phytosterol and/or phytostanol ester(s) (PSE) dissolved or dispersed in an edible oil and/or fat. Preferably said oil is olive oil, canola oil or fish oil. This composition has been shown to reduce bld cholesterol and triglycerides levels and assist in preventing or treating bld oxidative stress, thus inhibiting the atherosclerosis cascade. Furthermore, this composition has been shown to maintain and preserve the body's natural defense mechanisms, such as the paraoxonase 1 (PONl) enzyme, whose activity is dramatically reduced when oils and fats are consumed in the diet. Moreover, equal amounts of these phytosterolesters and DAG in fats and oils maintained normal activity levels of PONl in ApoE° knockout mice (WO 24/6915). These combinations of phytosterol esters and DAG can be easily used to replace part, most, or all of the fat content of the fd products of the invention. The level of the phytosterol esters and DAG combination in each fd item of the invention can be controlled to provide phytosterol esters levels according to current recommended daily allowances (EDA) in such a way that, at least, the full RDA can be achieved through the consumption of several servings of a specific fd product, through the consumption of a single serving of different fd products all containing the phytosterol esters/DAG combinations or in a single serving of a specific fd product. It has now been surprising found that these combinations are also beneficiary for diabetics or pre-diabetics, as will be shown in the examples below. Omega-3 fatty acids, such as alpha-linolenic (18:3) acid and especially docosahexaenoic acid (22:6, DHA) and eicoeapentaenoic acid (2:5, EPA) have been shown to have beneficial effects on cardiovascular health. These fatty acids, produced from different marine animals and organisms, particularly from cold water fish, as well as from different microbial and algal sources, have been shown to lower bld triglycerides levels and render anti-inflammatory, antithrombotic and immunomodulatory effects. Omega-3 linolenic acid, such as found in flax seed oil, has also been shown to have beneficial effects on lowering the risk of MI and fatal ischemic heart disease in women and in men. Long chain omega-3 fatty acids (DHA, EPA) have been shown to exert beneficial effects and current recommended intakes are above 65mg/day and even higher. The omega-3 fatty acids and especially their long-chain polyunsaturated members (DHA and EPA) suffer from stability problems in light of their oxidation sensitivity. The same oxidation problem is also related to organoleptic problems in which products containing said fatty acid suffer from "fish-like" odor and taste. Although the algal and microbial omega-3 LC-PUFA have somewhat enhanced stability and lesser organoleptic problems, these also are not easy to use in fd products. Recently different methods have been devised to overcome the above problems. These include encapsulation of the omega-3 fatty acids in different fd compatible matrices, as well as the use of special purification and distillation techniques and special antioxidants or antioxidants mixtures. Thus, the fd products of the invention may be designed to include these beneficial dietary ingredients at adequate levels in a variety of daily fd products. Oxidative stress and other adverse effects related to oxidative damage have been shown to be controlled, at least to some extent, by different dietary ingredients with an anti-oxidation capacity. These can include plant extracts such as rosemary extract, lycopene, zeaxanthin, polyphenols (such as hydroxytyrosol found in olive oil, grapes, pomegranates, etc.), vitamins (tocopherols and especially vitamin E, ascorbic acid), minerals (Zinc, Selenium or Calcium), coenzyme Qio and beta carotene. All these ingredients, as well as other antioxidants, have been extensively investigated and shown to have beneficial effects on the health of individuals. These antioxidants have also been used as dietary supplements. A few of these, especially vitamin E and ascorbic acid derivatives have been used at low levels (lower than .2%wt) in fds aa fd antioxidants and in some cases at even higher levels in order to deliver said antioxidants to exert their beneficial activity on the fd consumers. No attempts have been made to use antioxidants in specialty diabetic fd products as part of a diabetic functional fd methodology addressing their CVD health problems, as suggested herein. A variety of herbal or plant extracts, such as soy proteins, isoflavones, carotenoids (beta-carotene, lutein, zeaxanthin) and garlic extracts have been shown to beneficially influence different CVD risk factors such as high bld cholesterol level, high bld triglycerides level. No attempts have been made to use such plant extracts in specialty diabetic fd products as part of a diabetic functional fd methodology addressing their CVD health problems, as suggested herein. Other ingredients or combinations of ingredients have also been shown to have beneficial effects and can be used as dietary ingredients in the fd products of the invention. For example, a combination of vitamin Be, vitamin Biz, and folic acid has been shown to lower bld level of homocysteine, high levels of the latter have been recognized as a CVD risk factor or bio-marker. Additionally some dietary active ingredients with CVD related benefits have been shown to act synergistically to further reduce the risk of CVD. Such a combination includes bld cholesterols lowering ingredient phytosterols and soy proteins. In one embodiment of the fd article of the invention, said article is functional in the treatment and/or prevention of CVD risk factors, such as hyperlipidemia, which may be hypercholesterolemia and/or hypertriglyceridemia, oxidative stress and atherosclerosis, particularly in diabetic or diabetes-prone individuals. Thus, the fd article of the invention is geared to offer preventive or therapeutic health benefits, especially with regards to the cardiovascular health of subjects suffering from or prone to diabetes. As mentioned above, diabetes-prone subjects are individuals that fulfill at least one of the following criteria: (a) have a family history of diabetes mellitus (parents or siblings); (b) are obese; (c) belong to a race or ethnicity which have a higher incidence of diabetes, for example African American, Hispanic, Native American, etc.; (d) are 45 years old or older; (e) were previously identified with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT); (f) have hyperinsulinaemia; (g) have hypertension, Le. bld pressure above 14/9 mm Hg; (h) have dyslipidemia: HDL lower than 35 mg/dL and/or triglycerides above 25 mg/dL; (i) have a history of gestational diabetes or delivery of babies weighting above 4.1 kg. A subject will be considered diabetic if his fasting plasma glucose is 126 mg/dl or over. Normal range of fasting plasma glucose is 6 -19 mg/dl. In another embodiment of the fd article of the invention, said article further comprises at least one active agent which is functional in the treatment and/or prevention of CVD risk factors, such as hyperlipidemia including hypercholesterolemia and/or hypertriglyceridemia, metabolic disorders such as metabolic syndrome and obesity also considered diabetes related risk factors, oxidative stress and atherosclerosis. Said active agent may replace some or preferably all the fat constituents of the fd product described in the invention. The fd product described herein should be considered beneficial to any condition that renders a subject, especially a diabetic or a per-diabetic individual, prone to acute CVD. As herein described, said active agent is any one of phytosterols and/or phytostanols esters and their derivatives, diglycerides (DAG), combinations of phytosterol esters and DAG (specifically combinations having phytosterol-esters levels higher than DAG levels, optionally dissolved or dispersed in an oil and/or fat), anti-osidants, natural herb and plant extracts (for example garlic extract, soy protein, soy isoflavones, or lycopene), omega-3 fatty acids, as well as other dietary ingredients or any combination thereof The anti-oxidant may include natural or synthetic anti-oxidants, such as polyphenols, vitamins, especially tocopherols, or minerals, such as zinc and selenium, known to exert positive and healthy effects on heart-health of the general population. In addition, said active agent may include omega-3 lipids, in the form of free fatty acids, ethyl-esters, triglycerides, phospholipids or any other derivative or delivery platform, chemical or technical. These lipids have been shown to positively affect general heart-health indications in the general population as well as CVD prone population. As mentioned above, the active ingredients can also be pharmaceutical in nature, such as statins, bile acid sequestrants, ezetimibe, bld diluting agents, and bld pressure lowering agents. In one embodiment the active agent comprised in the fd product of the invention may be any ingredient functional in reducing at least one of the following parameters: total cholesterol serum level, non-HDL cholesterol serum level, total cholesterol/HDL ratio and triglycerides serum level in an overweight and/or obese and/or diabetic subject and/or diabetic-prone subject, as illustrated in Examples 1 and 2, Figures 16. High cholesterol in the bld is a major risk factor for heart and bld vessel diseases such as atherosclerosis and stroke. The term "total cholesterol" relates to three major kinds of cholesterol: High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), and Very Low Density Lipoprotein (VLDL). Bld total cholesterol values less than 2 mg/dL, and LDL Cholesterol of 1 mg/dL or less are considered optimal by the National Heart, Lung, and Bld Institute. Excessive amount of LDL cholesterol in bld is deposited in the arteries, therefore, LDL level of less than 13mg/dL is recommended and lmg/dL is considered optimal. LDL amount is commonly estimated by calculating its part from the total cholesterol, HDL, and triglycerides results ("LDL Gale") or by a directly measurement. HDL cholesterol is considered to be protective against heart disease by helping removing excess cholesterol deposited in the arteries. High HDL levels are associated with low incidence of coronary heart disease. Bld values of 35 mg/dL and higher are recommended. The total cholesterol to HDL cholesterol ratio is a number that is helpful in predicting atherosclerosis and is validated as a powerful predictor for myocardial infraction (MI). The number is obtained by dividing total cholesterol by HDL cholesterol. (High ratios indicate higher risks of heart attacks, low ratios indicate lower risk). An average ratio is about 4.5 and a preferred ratio would be 2 or 3 or less than 4. Triglycerides are the major storage form of fat in the body. In some people, abnormally high bld triglyceride levels (hypertriglyceridemia) are inherited, but it is often caused by non-genetic factors such as obesity, excessive alcohol intake, diabetes mellitus, kidney disease, and estrogen containing medications such as birth control pills. High levels of triglycerides increase the risk of coronary heart disease (CHD) by speeding up plaque build-up on arteries (atherogenesis) and increasing the risk for thrombosis, which may lead to myocardial infarction. Desired triglycerides bld level range from 15-2rng/dL. High levels of triglycerides should be treated aggressively with, low fat diets and, if needed, medications. The first step in treating hypertriglyceridemia is a low fat diet with a limited amount of sweets, regular aerobic exercise, loss of excess weight, reduction of alcohol consumption, and stopping cigarette smoking. In patients with diabetes mellitus, meticulous control of elevated bld glucose is also important. Therefore, the consumption of the nutritional product of the invention would be considered highly beneficiary. If necessary, additional pharmaceutical agents such as fibrates (for example gemfibrozil), nicotinic acid, and statin derivatives can be added to the nutritional product. Said pharmaceutical agents, also may affect the overall lipid profile: Lopid not only decreases triglyceride levels but also increases HDL cholesterol levels and LDL cholesterol particle size; nieotinic acid lowers triglyceride levels, increases HDL cholesterol levels and the size of LDL cholesterol particles, as well as lowers the levels of Lp (a) cholesterol; statins are effective in decreasing triglyceride as well as LDL cholesterol levels and in elevating HDL cholesterol levels. The fd product of the invention is also functional in reducing the body weight and/or the serum insulin level in an obese and/or diabetic subject as illustrated in Example 2 and Figure 11. Insulin is a peptide hormone that enables the body to metabolize and utilize bld glucose by permitting the cells glucose uptake and lowering its concentration in bld. Inside the cell, glucose is either used for energy or stored in the form fat. Insulin drives to use more carbohydrate, and less fat, promoting to fat metabolic imbalance and obesity, considered risk conditions to develop diabetes and CVD, Therefore, it is desirable to control the bld insulin level whenever it overpasses normal values. Normal fasting insulin values range 5-2 mcU/mL (micro unit per milliliter). Particularly, said fd product is functional in ameliorating hyperinsulinemia (reducing the serum insulin level) in an insulin-resistant subject. High insulin bld level could be used as an indicator for insulin resistance, one of the main leading conditions for developing Type 2 diabetes, and usually occurring in individuals suffering from hypertension, cardiovascular disease, and obesity. Usually, the glucose/insulin ratio (6/1 ratio) index is used for the diagnosis of insulin resistance, which low values depict higher degree of insulin resistance. A desired G/I ratio will be of less than 4.5. Since the fd product of the invention reduces the serum insulin level, measurement of the G/I ratio may be used as a simple test for evaluating the therapeutical effectiveness of the said fd product In a more particular case, said fd product is effective in ameliorating hyperinsulinema or preventing progression of insulin resistance in an obese subject prone to develop diabetes. Physical activity and weight loss help the body the better respond to insulin and overcome insulin resistance. Body weight reduction accomplished by consuming the nutritional product of the invention and being physically active, may prevent the evolution of the insulin resistance condition into developing Type 2 diabetes. By changing nutritional habits and lsing weight it is possible to return prediabetic individuals to normal bld glucose levels and reduced the risk of diabetes by 58 percent. In another embodiment, the fd product of the invention is functional in reducing the body weight, inhibiting body weight gain and reducing insulin resistance in obese, subjects with metabolic imbalances such as diabetes or metabolic syndrome, or in an individual prone to develop diabetes or obesity. Furthermore, these active ingredients may assist to suppress WAT accumulation, remodel body fat distribution and reduce visceral fat weight, by shifting fats accumulation, from the visceral tissues to the peripheral tissues, resulting in prevention or inhibition of metabolic syndromes in obese, overweight, diabetic, pre-diabetic, or in an individual prone to diabetes or obesty, or by simply ameliorating diabetic patients' conditions. Dietary ingredients that address weight gain and management as well as fat distribution include diglycerides (DAG). Replacement of daily fat intake with DAG has been shown to promote weight loss. Additionally, conjugated linolenic acid (CLA) has also been extensively researched and connected to health benefits related to weight management. Recently, novel triglycerides alkyl substituted at the alpha position of their fatty acids have been shown to inhibit digestion Upases and promote satiation feeling resulting in overall weight loss. Such dietary ingredients, as well as other ingredients addressing weight gain, weight management and controlling fat distribution are all within the scope of this invention. Untreated diabetes might evolve to develop a variety of secondary disease complications. The fd product of the invention is intended to be use for reducing the risk of life threatening long term diabetes complications and ameliorate the deterioration of life quality in an obese and/or diabetic subject. Diabetes complications are classified in three major categories macrovascular, microvascular and of neurological origin. People with diabetes usually develop heart and bld vessel disease. Diabetes carries an increased risk for heart attack, stroke, and complications related to pr circulation. Other diabetes complications may include kidney diseases, eye problems that may lead to blindness, diabetic neuropathy and nerve damage, many different ft problems resulting from nerve damage or pr bld flow that may conduct to amputations, skin disorders which sometimes is the first sign that a person has diabetes, gastroparesis and depression. Therefore, the fd product of the invention should be considered to be used for the treatment and/or prevention of any one of the diabetes complications selected from the group of retinopathy, nephropathy, diseases of the large vessels supplying the legs (lower extremity arterial disease), coronary heart or artery diseases, cerebrovascular diseases and disturbed neural function afflictions, or any other condition which may lead to blindness, end-stage kidney disease (ESED) and amputations, myocardial infractions, stroke or any other complication mentioned above. In an additional embodiment, the fd product of the invention further comprises active agents, dietary or pharmaceutical ingredients, for addressing other diabetes related problems. The active agent of said fd product which is functional in the prevention and/or treatment of acute cognitive decline is any one of phosphatidylserine, ginko biloba, brahmi (Bacopa monneri), and omega-3 containing fat and said acute cognitive decline may be associated or induced by diabetes. Several cognitive related dietary ingredients can be used in the fd products of the invention. Phosphatidylserine, a major brain phospholipid mainly produced from soy phospholipids, has been previously and extensively shown to improve memory and other cognitive functions in the elderly and in younger populations. Several herbal extracts, such as ginko biloba, have also been claimed to have similar cognitive benefits. Omega-3 fatty acids and antioxidants, which both have been connected to the promotion of heart health, have also benefits on cognitive functions. Antioxidants are connected to brain health since many cognitive decline processes are the result of oxidative damage to brain cells and tissues. In a further embodiment of the invention, the fd product further comprises active agents which are functional in the prevention and/or treatment of acute eye conditions associated with Type 2 diabetes, wherein said active agents are vitamins, antioxidants, and other natural eye-health promoting ingredients or extracts. The amount of the dietary or pharmaceutical ingredients which proactively promote the health of the heart, brain, and eye, that is in the fd products of the invention can be based on their specific RDAs or other recommendations of different organizations or based on the results of related clinical trials. Each ingredient can be given at its full RDA per serving or alternatively only part of the RDA can be given in each serving, depending on the variety of fds or sources available for daily consumption that deliver the same ingredient or the average number of servings usually consumed from the specific fd product. The guiding rule of the invention is that the active ingredient could be consumed at an adequate level to exert its beneficial health effects through one or more fd products and/or servings, either once a day or through different meals during the day. At least 5% of the recommended, official or non-official, daily intake of said ingredients should be provided by the fd products of the invention. The active dietary or pharmaceutical ingredients may be added at any stage during the fd product preparation or processing and either through its major mass or through fillings, coatings, etc. The active dietary or pharmaceutical ingredients may also exert technical or functional properties to the fd product, such as related to texture, stability, shelf-life, organoleptic and sensorial qualities and appearance. As described herein, the Ibod product of tibe invention is preferably for use by any subject either suffering from diabetes or prone to become diabetic. Such fd articles can be consumed by diabetics, as part of their unique diets, for treating or addressing their cardiovascular risk factors. Optionally these fds can be used by pre-diabetic individuals in order to prevent or inhibit the manifestation of diabetes. The fd product described herein may be any one of dairy products, bakery products, condiments, beverages and drinks, snacks, candies, ice-creams and frozen desserts, morning cereals, nutrition bars, chocolate products, prepared fds, grain products and pasta, soups, sauces and dressings, confectionery products, oils and fats products, dairy and milk drinks, soy milk and soy dairy- like products, frozen fd products, prepared meals and meal replacements, meat products, cheeses, yoghurts, breads and rolls, yeast products, cakes and ckies and crackers. The present invention is defined by the claims, the contents of which are to be read as included within the disclosure of the specification. Disclosed and described, it is to be understd that this invention is not limited to the particular examples, process steps, and materials disclosed herein as such process steps and materials may vary somewhat. It is also to be understd that the terminology used herein is used for the purpose of describing particular embodiments only and not intended to be limiting since the scope of the present invention will be limited only by the appended claims and equivalents thereof. It must be noted that, as used in this specification and the appended claims, the singular forms "a", "an" and "the" include plural referents unless the content clearly dictates otherwise. Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises' and "comprising", will be understd to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps. Examples In vivo experiments The effect of different dietary functional oils and lipids on CVD was estimated by measuring some parameters known as CVD risk factors (body and fat weight, bld lipid levels, glucose and insulin bld levels) in Psammomys obesus, an experimental animal model for nutrition-dependent type 2 diabetes. Psammomys obesus, an Israeli sand rat, is a herbaceous gerbil that when maintained in captivity and given free access to non-purified high energy (HE) rodent diet tends to display heterogeneous glucose and insulin levels, ranging from normoglyeemia and normoinsulinemia to obese diabetic animals with progressive hyperglycemia and hyperinsulinemia. The course of the obesity and diabetes developed in these animals can be characterized in four phenotypic states: normoinsulinemia and normoglycemia (State A), hyperinsulinemia but normoglycemia (State B), hyperinsulinemia and hyperglycemia (State C), and hypoinsulinemia and severe hyperglycemia as a result of p-cell degranulation, and markedly reduced pancreatic insulin content (State D). The Psammomys obesus gerbil animal model has been shown in numerous studies to be an ideal natural model of Type 2 diabetes disease in humans because it demonstrates an increased tendency to develop diet-induced diabetes, which is associated with moderate obesity. This model has been used also to study the prediabetic state, in order to determine the development of metabolic changes such as hyperinsulinemia , hyperglycemia, and obesity, leading to diabetes [Zimmet P. (21) Nature 414:782-7, review by Ziv E. and Kalman R. (21), In Animal models of diabetes, eds. Sima and Shafrir, Harwd academic publishers, 327- 342]]. In humans, as well as in the Psammomys obesus model, diabetes is associated with obesity and nutritional values and characteristics of their diets are of importance in the onset and evolution of the disease (Shafrir E. and Gutman A. (1993) JBasic din Physiol Pharmacol 4: 83-99; Kalman R, et al (1993) JBasic Clin Physiol Pharmacol. 4: 57-68). The selection of the Psammomys obesus as the present experimental model, contributes to the understanding of the role that dietary functional oils and lipids play in the development and/or treatment of obesity and non-insulin dependent diabetes mellitus. The gerbil experimental model is known to be slightly superior for assessing bld lipid-lowering effects as compared to hamster models. Rats and mice are considered inappropriate because their plasma and liver cholesterol is relatively less responsive to dietary cholesterol challenge. In the Psammomys obesus model a sequential transition from normal to impaired insulin sensitivity accompanied by increased adiposity prior to insulin resistance and obesity occurs in a manner similar to that observed in the human Type 2 diabetes susceptible populations. Materials and Methods The animal studies were approved by the Institutional Animal Care and Use Committee of Hebrew University and the Hadassah Medical Organization, Animals: Male Psammomys obesus gerbils (age 2.-3.5 months) obtained from Harlan Laboratories Ltd. (Jerusalem, Israel) were grown at the Hebrew University facilities. After weaning period, Psammomys obesus were maintained on a low-energy diet containing 2.88 kcal/g (Koffolk Ltd., Petach Tikva, Israel) prior to diabetes induction. Experimental model -1 Psammomys obesus were switched to a high energy diet containing 2.93 kcal/g (Tekled Global, Madison, Wis., USA) for 4 weeks, and the animals that developed diabetes (~7% of the animals in the Psammomys obesus colony) were selected for the feeding intervention study. Animals were considered diabetic if their non-fasting bld glucose was greater than 18 mg/dL. Diabetic gerbils were randomly assigned to groups (8-1 animals per group) and fed for another 3.5 weeks with the different high energy experimental diets, as specified in Table 2. The high fat diets supplied differ in their fat content. Water and fd were supplied ad libitum; Psammomys obesus bld glucose concentrations and body weights were monitored every other day. By the end of the experiment, the gerbils were anesthetized with ketamine (Ketalar; Parke- Davis & Co., Gwent, United Kingdom) and exsanguinated by cardiac puncture. Bld samples were collected into an EDTA-wetted syringe and used for biochemical analyses. Experimental model - II Sixty adult male Psammomys obesus gerbils were randomly assigned to 2 high energy diets containing 2.93 kcal/g (n=3), that differed only in the fats and lipids content; either Harlan-high energy diet (Tekled Global, Madison, Wis., USA) or diet C (Table 2). Water and fd were supplied ad libitum for 4.5 weeks; body weights and bld glucose concentrations were monitored every other day. After 4.5 wk of feeding with the experimental diets, gerbils were deprived of fd overnight (16 h) and anesthetized with ketamine (Ketalar; Parke-Davis & Co., Gwent, United Kingdom) and exsanguinated by cardiac puncture, and bld samples were collected into an EDTA-wetted syringe. The liver and the epididymis fiat were excised and weighed. Bld taken from the heart was used for biochemical analyses. Glucose analysis Bld glucose concentration was determined by the enzymatic glucose analyzer, Glucometer Elite (Bayer, Elkhart, Indiana., USA) on bld samples taken from the tail vein. Lipid analysis Plasma samples obtained from EDTA-treated bld samples (separated at 12, x g for 15 min) were analyzed for total cholesterol, total triglycerides and HDL-cholesterol levels by colorimefcric methods (Boehringer Mannheim, Mannheim, Germany). LDL-cholesterol level was calculated using the Friedewald equation. Insulin analysis Insulin levels were assessed by radioimmunoassay using a human primary antibody (Phadesph; Kabi Pharmacia Diagnostics, Uppsala, Sweden). Statistical Analysis Data was analyzed by one-way analysis of variance (ANOVA) to assess the differences among the experimental groups. Differences between mean values were evaluated by the Student's two tailed i-test. Nutritional Diets Standard milling procedures were used to incorporate different treatment oils (custom-made manufactured by Harlan Telded Ltd, USA) into standard gerbil chow. The 218SC+F high-energy diet was used as a control (Tekled Global, Madison, Wis., USA), The composition of the custom-made diets was similar with respect to the fd and nutrient content. All diets were made from the same basal mix while the variable component was the supplemented fats. This basal mix was a slightly concentrated version of 218SO+F without a fat source. When the fat source and cholesterol were added, the finished products were very similar to the original 218SC+F, with the exception of the fat and cholesterol components. Diets were prepared according to the scheme below: 1. HSFA= Highly enriched with saturated fatty acids oil 2. HMUFA= Highly enriched with mono-unaturated fatty acids oil, i.e. HOSO 3. Contain 2% (w/w) plant sterols esterified to indicated base oil derived fatty acids and 15% (w/w) dietary diacylglycerol presenting similar fatty acids composition as base oil 4 Dietary plant sterol to cholesterol ratio of 5:1 37 Example 1 - Effect of mono- and poly-unsaturated fatty acid diets on diabetic gerbils' bld lipids content The present experiment studies the effect of consumption of Diet A (PS-E + DAG, comprising soy sterols esters with HOSO oil (PS-E) and diacylglycerols derived from HOSO oil (DAG)) and Diet B (PS-E + DAG, comprising soy sterol esters with flaxseed oil (PS-E) and diacylglycerols derived from flax seed oil (DAG), having high content of polyunsaturated fatty acids) on the profiles of plasma lipids. Diabetic male Psammomys obesus gerbils were assigned randomly to the indicated diet groups (8-1 gerbils each) for 3.5 weeks feeding period (as presented in Table 1 and Table 2). By the end of the experimental feeding period, bld samples were collected for plasma lipids analyses. The total cholesterol plasma level in the different diet groups significantly varied as illustrated in Figure 1. A striking difference can be observed among the controls and the diet-treated groups (diets A and B), yet all animals maintained similar basal levels of hyperglycemia and hyperinsulinemia symptoms. Diabetic HMUFA-fed and HSFA-fed Psammomys obesus showed similar total cholesterol concentrations in plasma (P-value=.24), while the other Psammomys obesus groups which were fed with diet A and diet B had a substantial and significant reduction in the levels of total cholesterol (35% and 42%, respectively; Pvalue= .31, .28) relative to saturated fat fed gerbils. The high statistical significance of these results (shown by ANOVA, Pvalue= .3) suggest that both preparations A and B, induce a very potent hypocholesterolemic effect. Similar results (~43% reduction) of plasma total cholesterol reduction were reported for male Mongolian gerbils (Meriones unquiculatus) frequently fed with 6:1 phytosterol to dietary cholesterol for four weeks [Hayes et al. (22) J. Nutr. 132:19834988]. 38 Similarly, as shown in Figure 2, consumption of either diet A or diet B induced a remarkable and significant reduction in the level of plasma non-HDL cholesterol (47% and 59%, respectively; P-value=,22, .19) relatively to diabetic gerbils fed with HSFA diet. In the HSFA and HMUFA diet consumption groups (controls), similar non-HDL cholesterol concentrations were measured (Pvalue= .22). ANOVA comparison between these diets matrices suggested a highly significant difference (P-value=O.OQl). Non-HDL-C serum level is considered a strong predictor of future risk for cardiovascular comph'cation among patients which not necessarily exhibit any vascular disease symptom. Non-HDL-C was recently recommended by the National Cholesterol Education Program, Adult Treatment Panel IH as a secondary treatment target (after LDL-C) in patients with elevated triglycerides. Both Figure 1 and Figure 2 highlight the prominent hypocholesterolemic effect of either preparation A or preparation B of the invention inasmuch as both resulted in reduced total and non-HDL cholesterol plasma levels; in comparison to consumption of diets based on either saturated fatty acids or high oleic sunflower oils. Contrarily, no significant difference was observed in the plasma HDLrcholesterol level of any of the gerbils tested groups (ANOVA P-Value=.11). The calculated total cholesterol to HDL-cholesterol ratio (Total/HDL) illustrated in Figure 3 and further statistically analyzed (ANOVA P=.5) showed a significant difference between the different dietary treatment groups. The Total/HDL ratio in the HMUFA diet consumption group was comparable to the ratio seen in the HSFA-fed obese diabetic Psammomys obesus (P-value=.14). In spite of these results, when diet A or diet B of the invention were provided to these sand rats, a remarkable and significant decreased (23%; P-Value.12, and 27%; P-Value.7) in the Total/HDL cholesterol ratio was measured relatively to the control group (HSFA-fed group). 39 In Type 2 diabetic patients dyslipideraia is manifested by elevated triglycerides level and reduced HDL cholesterol level. Usually, the LDL cholesterol amount does not significantly differ in Type 2 diabetic patients and non-diabetic individuals, but some LDL appears as a denser particle form (apolipoprotein B) which may increase the atherogenic risk despite the total and LDL cholesterol normal values. In some cases, diabetic patients may have elevated levels of non-HDL cholesterol (LDL plus VLDL cholesterol). The ability of the nutritional components of diets A and B to reduce the non-HDL level in such a short period of time is of major relevance in reducing the risk, preventing and treating CVD. The use of the A and B fd diet matrices should be considered as highly beneficial for dyslipidemia and LDL-cholesterol related atherogenicity treatment, together or independently of other conventional pharmaceutical drug treatments. The dietary treatment of obese diabetic Psammomys obesus either with diet A (soy sterols esterified to long chain monounsaturated fatty acids in a diacylglycerol HOSO matrix) or diet B (soy sterols esterified to long chain polyunsaturated fatty acids in a diacylglycerol flax seed oil matrix) resulted in a significant reduction of the total cholesterol and non-HDL cholesterol values, despite said diets were supplemented with cholesterol. These results reveal a new non-pharmaceutical, non-synthetic ajnd not-needing physical intervention tactic for changing the body lipid management in a short period of time, by a simple nutritional habit adjustment which could be of benefit to any diabetic, obese, or subject at risk of developing any high cholesterol-related complication. The success efficiency of the nutritional product of the invention is based on the its special composition of low or glucose free content, balance fat content and the addition of a proactive agent (pharmaceutical or nutritional) for addressing the needs of diabetics or diabetic-prone individuals. Although, each one of the separated components may have some mild influence on the lipid profile, the synergistic activity of the components, as well as their relative ratios in the fd 4 product of the present invention are the reasons for making this product so effective in the treatment of lipid imbalanced conditions associated with diabetes. Example 2 Effect of monounsaturated fatty acids diet on "pre-diabetic" gerbils Pre-diabetic individuals may exhibit high total cholesterol, LDL cholesterol, and triglycerides levels but low HDL cholesterol level as compared to non-diabetic individuals. This experiment comes to evaluate the effect of diet C, a cholesterol free diet, on the lipids bld level and lipids management in diabetic prone gerbils. Sixty adult male Psammomys obesus gerbils were randomly assigned to two different high energy diets (n=3), which contained 2.93 kcal/g and only differed in their fat and lipids content. The effect of diet C (Table 2) was compared to the effect of the basic Harlan-high energy diet (Tekled Global, Madison, Wis., USA). After 4.5 weeks of experimental diet feeding, the gerbils were deprived of fd overnight (16 h) and sacrificed. The liver and epididymal fat were harvested and weighed. Collected bld samples were used for biochemical analyses. The effect of diet G on the development of obesity and diabetes in Psammomys obesus (an experimental model of nutritionally induced diabetes type 2), was compared to the rodent standard high energy (HE) diet According to pervious publications [Ziv and Kalman (21), in Animal Models of Diabetes, eds. Sima and Shafrir, Harwd academic publishers, 327-342; Kalman R. et at (1993) J Basic Clin Physiol Pharmacol. 4: 57-68], hyperglycemia is developed relatively fast, within 7-14 days of HE diet intake. Usually, gerbils will die after 4-7 days of HE diet, as consequence of p-cell function loss (phase D). In our study, by the end of the feeding period there was a slightly lower percentage, however typical, of diabetic animals in the diet C-fed 41 group (73.3%) compared with HE diet (8.%). This indication was further correlated with higher survival rate of the Psamrnomys obesus that consumed diet C (97%), whereas gerbils consecutively fed with HE diet demonstrated a somewhat lower survival rate (87%) by the day the animals were sacrificed, 4.5 weeks after the beginning of the feeding experiment. Consumption of diet C induced a major reduction of the total cholesterol level, compared with HE diet (23% decrease with P-value=.55 as seen in Figure 4). A more prominent and statistically significant reduction was observed in the non- HDL cholesterol level (41% decrease with P-value=.26 as seen in Figure 5). A small though highly significant reduction in the total cholesterol/HDL ratio was observed among gerbils fed with diet C ae compared to HE fed gerbils (7% decrease with P-value=.12 as seen in Figure 6). This diminution could not be attributed to a parallel reduction in the HDL cholesterol level, since only a mild tendency was perceived when these two diets were compared (P-value=.1). As both diet C and HE contained no dietary cholesterol supplementation, it can be concluded that the efficacy of specialty fd products containing proactive ingredients such as preparation A (see Example 17) is manifested by actually lowering total cholesterol both dietary and endogenous cholesterol, and especially LDL-cholesteroI. The dietary diacylglycerol content in diet C had no effect on the gerbils' triglycerides plasma level, as it was expected accordingly to previous reports [Murase et al (21) J. Lipid Res. 42:372-378; Murase et al. (22) J. Lipid Res. 43:1312-1319]. Obesity and the metabolic disorder, which are recognized as risk factors for noninsulin dependent diabetes mellitus (NIDDM) and insulin resistance (Matsuzawa et al. (1995) Ann N Y Acad Sci 748:399-46], are identified as being the outcome of a disequilibrium between energy uptake and energy expenditure. 42 Increased body fat mass is frequently accompanied by elevated circulating free fatty acids, insulin, tumor necrosis factor-a, and leptin, suggesting that these molecules may play important roles in the development of insulin resistance in obese individuals. In order to elucidate the connection between obesity and insulin resistance some of the following anthropometric parameters were evaluated. Consumption of diet C resulted in a marked reduced endpoint bodyweight as compared to HE fed gerbfls (8,3% decrease with P-value=.11 as seen in Figure 7). Also, the epididymal white adipose tissue (WAT) weight, but not the liver weight (P-value=.41), was remarkably reduced in diet C fed gerbils as compared to the HE control group (2% decrease with P-value=.11 as seen in Figure 8). A highly significant correlation of reduced relative size of organs expressed by the epididymal WAT to liver weight ratio is illustrated in Figure 9 (21% decrease, P-value=.25). According to these results, it can be concluded that fd products of the invention containing proactive ingredients such as preparation A not only affect the serum lipid profile but are also involved in the body fat accumulation and distribution. Diet C showed a significant effect on fasting plasma insulin levels as compared to the control HE group (42% decrease with P-value=.6 as seen in Figure 1). Under fasting conditions, Psammomys obesus revealed a less pronounced hyperinsulinemia though the overall hyperglycemia remained similar (Pvalue= .26). As expressed in Figures 11 and 12, gerbils fed with diet C presented a lower serum insulin/bodyweight index and a lower serum insulin/bld glucose level index as compared to HE fed gerbils. Therefore, for similar bodyweight or glucose level, animals fed with diet C showed a lower plasma insulin level (88% decrease with P-value=O.l5 and 49% decrease with P-value=,15 respectively). The importance of the fasting insulin reduction should be lked in the context of reduced fat tissue accumulation and combined roll in insulin resistance propagation. The capacity of diet C and correspondingly fd products containing preparation A to invert the metabolic unbalanced situation, has proven its beneficiary effects and effectiveness which should be applied for the prevention and treatment of diabetes-prone individuals, diabetic patients at different stages and other individuals suffering from other lipid unbalanced afflictions. The proposed simple care which can be achieved by the use of the fd products of the invention, such as products containing preparation A, is expected to be of great profit for inflicted individuals, since its beneficiary results are evident after a relatively short period. Example 3; Yoghurt drink with phytosterols The fruit flavored yoghurt drink of the invention is designed primarily for the diabetic and pre-diabetic populations and it includes no sugar, has a low fat content as to not contribute to the hypertriglyceridemia and/or hypercholesterolemia associated with diabetic conditions. Furthermore, the yoghurt drink is fortified with soy phytosterols, providing 1% of their RDA, in order to further lower high bld cholesterol levels. Ingredients: pasteurized milk, maltitol, fruit puree/concentrate, milk powder, processed starches (E1422, E1442), natural stabilizer (E44), flavor agents, citric acid, soy phytosterols. Nutritional values (1ml): Protein 3.1g, Carbohydrates 16.4g, Pat 1.5g (1.18g mjlfr fat, .32g soy phytosterols), Calcium llOmg, Sodium 76 mg. Each 25ml serving contains .8g of soy phytosterols (1% RDA). 44 Example 4; Soy drink with soy isoflavon.es and proteins The natural flavored soy drink of the invention is designed primarily for the diabetic and pre-diabetic populations and it includes no sugar, has a low fat content as to not contribute to the bypertriglyceridemia and/or hypercholesterolemia associated with diabetic conditions. Furthermore, the soy drink is fortified with soy isoflavones and proteins, in order to further lower high bld cholesterol and LDL cholesterol levels. Isoflavones can preserve the vascular elasticity and inhibit atherosclerotic cascades. Soy proteins have also been shown to have a cardiovascular protective effect and may reduce the risk to heart disease. Ingredients: water, soy beans, artificial sweeteners, poly alcohols, calcium fortification, acidity regulators (E-339, E-452), salt, flavor, stabilizer (E-47), soy isoflavones. Nutritional values (1ml): Protein 3,5g, Carbohydrates 3.9g, Fat Ig (of which 1% saturated), Calcium 15mg, Sodium 5 mg, fiber .9g, Each 25ml serving contains img of soy isoflavones, and 8.75g of soy proteins (35% RDA). Example 6; Salad dressing with garlic extract The garlic flavored salad dressing of the invention is designed primarily for the diabetic and pre-diabetic populations and it includes no sugar, has a low fat content as to not contribute to the hypertriglyceridemia and/or hypercholesterolemia associated with diabetic conditions. Furthermore, the salad dressing is fortified with garlic extract, in order to further lower high bld cholesterol and LDL cholesterol levels as well as high bld pressure. Ingredients: water, vinegar, olive oil, mustard, salt, wheat, soy beans, spices, fibers, plant stabilizers (E-45, guar gum), processed corn starch, citric acid, sucralose, beta-carotene, parsley, garlic extract. Nutritional values (1ml): Protein .84g, Carbohydrates 3.6g (of which .7g dietary fibers), Fat 1.6g (of which 12% saturated), Calcium 15mg, Sodium 3 mg, and garlic extract Smg. Each serving (15 mL) contains Smg of garlic extract, the average common level used in most clinical studies. In comparison, a diet, low fat version of a salad dressing, marketed as contributing to weight loss and even as adequate to diabetics contain 2.9g/lQOg of fat, of which about 3% are saturated. Example 6; Dairy drink with vitamins Be, Bi2 and folic acid The fruit flavored milk drink of the invention is designed primarily for the diabetic and pre-diabetic populations and it includes no sugar, has a low fat content as to not contribute to the hypertriglyceridemia and/or hypercholesterolemia associated with diabetic conditions. Furthermore, the milk drink is fortified with vitamins Be, BIZ and folic acid, in order to lower bld Homocysteine levels, an important CVD risk factor. Ingredients: water, pasteurized milk, milk powder, polyalcohols, fruit flavors, fruit concentrate, natural fd colorings, stabilizer E-41), Calcium (E-341), salt, vitamins Be, But and folk acid. Nutritional values (1ml): Protein 2.5g, Carbohydrates 14.6g, Fat 1.5g (of which 15% saturated), Calcium lmg, Sodium 5 mg. Each 25ml serving contains Be (.65mg, 5% EDA), Bi2 (1.2mcg, 5% RDA), and folk acid (2mg, 5% EDA). Example 7; Barbecue sauce with lycopene The Barbecue flavored sauce of the invention is designed primarily for the diabetic and pre-diabetic populations and it includes no sugar, has a low fat content as to not contribute to the hypertriglyceridemia and/or hypercholesterolemia associated with diabetic conditions. Furthermore, the sauce is fortified with lycopene, in order to lower oxidative damage, an important CVD risk fector. 46 Ingredients: water, tomato concentrate, maltitol, distilled vinegar, salt, mustard, tomato fibers, natural flavorings, spices, guar gum, paprika, pectin, lycopene. Nutritional values (1ml): Protein lg, Carbohydrates 36g, Fat (X4g, Sodium 5 nig. Each 15ml serving contains 25mg of lycopene (42mg of 6% lycopene preparation), Example 8; Light whole wheat bread with flax seed oil The light whole wheat bread of the invention is designed primarily for the diabetic and pre-diabetic populations and it includes no sugar, has a low fat content as to not contribute to the hypertriglyceridemia and/or hypercholesterolemia associated with diabetic conditions. Furthermore, the bread's fat fraction is comprised of flax seed oil, instead of other vegetable oils and fats customarily used in bread recipes. Flax seed oil is highly rich in omega- 3 Unolenic acid, a precursor of the "omega-3 LC-PUFAs, which lower bld triglycerides levels and reduce the risk of heart disease. Ingredients: whole wheat flour, rye flour water, corn flour, rice flour, oat bran, yeast, barley malt, millet, wheat gluten, flax seeds, sunflower seeds, salt, soybean flour, emulsifier (E-472), acids (E-3, E-33), preservatives, flax seed oil . Nutritional values (lg): Protein 12.2g, Carbohydrates 21. lg, Fat 3.1g, Sodium 41mg, dietary fibers 13.8g. Each serving (slice) contains about 5mg of flax seed oil, contributing about 25mg of alpha-linolenic acid. ; Chocolate flavored biscuits with selenium The chocolate flavored biscuits of the invention are designed primarily for the diabetic and pre-diabetic populations and it includes no sugar, has a low fat content as to not contribute to the hypertriglyceridemia and/or hypercholesterolemia associated with diabetic conditions. Furthermore, the 47 biscuits are fortified with selenium, an important mineral that plays an important role in many natural anti-oxidative enzymatic processes in order to lower oxidative damage, an important CVB risk factor. Ingredients: Wheat flour, maltitol, vegetable oil, starch, cocoa powder, salt, lecithin, leavening agents (sodium bicarbonate, sodium pyrophosphate), acesulfam K, natural antioxidants (rosemary extract), sodium selenate. Nutritional values (lg): Protein 13.3g, Carbohydrates 78g, Fat 6.5g (of which 2% saturated), Sodium 28 mg. Each serving (4 biscuits, 2g) contains 25mcg of selenium (5% RDI). In comparison, "regular" biacuits contain 12g/1g of fat, of which 35% are saturated fatty acids. Commercial diabetic biscuits, marketed as designed to address the needs of diabetics, contain lOg/lg of fat, of which about 45% are saturated. Example 1Q; Shortbread ckies with PSE+DAG combination The shortbread ckies of the invention are designed primarily for the diabetic and pre-diabetic populations and it includes no sugar, has a low fat content as to not contribute to the hypertriglyceridemia and/or hypercholesteroiemia associated with diabetic conditions. Furthermore, the fat fraction of the ckies is replaced by a combination of phytosterol esters (PSE) and diglycerides, characterized in higher PSE levels than DAG And clinically proven to lower both bld cholesterol and triglycerides levels as well as fight oxidative stress (see above). Ingredients: Wheat flour, maltitol, sorbitol, polydextrose, maltodextrin, natural flavor, whey protein concentrate, salt, sodium bicarbonate, oat fiber, emulsifiers, aspartame, xanthan gum, acesulfame K, phytosterol esters of canola fatty acids, diglycerides and triglycerides of canola oil. Nutritional values (lg): Protein 7g, Carbohydrates 8g, Fat 6.6g (of which 1% saturated), Sodium 25 mg. 48 Each serving (8 ckies, 3g) contains 2g of the PSE and DAG combination in canola oil, further contributing 1.3g of phytosterol esters and 2-4mg of DAG. In comparison, commercial diabetic biscuits, marketed as designed to address the needs of diabetics, contain 22g/1g of fat, of which about 2% are saturated and of course do not contain any additional proactive ingredients to lower the risk of diabetic related CVD. Even "regular" shortbread ckies contain lower levels of fat than the commercial diabetic brand (17.2%) although the level of saturated fats is indeed higher (48% of total fat). Example 11; Chocolate covered wafer with vitamins E+C and beta carotene The chocolate covered wafer of the invention is designed primarily for the diabetic and pre-diabetic populations and it includes no sugar, has a low fat content as to not contribute to the hypertriglyceridemia and/or hypercholesterolemia associated with diabetic conditions. Furthermore, the wafer is fortified by a combination of natural antioxidants, vitamin E, vitamin C, and beta-carotene, all promoting the lowering of CVD risks originating from oxidative damage. Ingredients: tnaltitol, milk powder, cocoa butter, cocoa mass, vegetable oil, wheat flour, soya flour, nuts, emulsifiers, salt, flavors, leavening agents. Milk chocolate containd cocoa solids 3% min., vitamin E, vitamin C, beta-carotene. Nutritional values (lg): Protein 8g, Polyols 39g, Carbohydrates 15g, Fat 15g (of which 2% saturated), Sodium 71 mg. Each serving (45g wafer) contains 9mg of vitamin C (1% EDI), 15mg of vitamin E (1% EDA) and 15mg of beta-carotene (1% EDI). In comparison, commercial diabetic chocolate covered wafer, marketed as designed to address the needs of diabetics, contain 34g/1g of fat, of which 44% are saturated and of course do not contain any additional proactive ingredients to lower the risk of diabetic related CVD. A "regular" version of chocolate covered wafer contains slightly lower levels of fat (33g/1g) and slightly lower levels of saturated fat ("only" 42% of the total fat). Example 12; Vanilla flavored sandwich ckies with DHA/EPA The vanilla flavored sandwich ckies of the invention are designed primarily for the diabetic and pre-diabetic populations and it includes no sugar, has a relatively low fat content as to not contribute to the hypertriglyeeridemia and/or hypercholesterolemia associated with diabetic conditions. Furthermore, the ckies are fortified with omega-3 LC-PUFA, specifically DHA and EPA for promoting the lowering of CVD risk factors and also contributing to the maintenance or improvements of cognitive abilities. Ingredients: maltitol, wheat flour, unsaturated vegetable oils, leavening agents, salt, lecithin, citric acid, flavors, Acesulfam K, antioxidant (rosemary extract), oil rich in DHA and EPA. Nutritional values (lg): Protein 6.7g, Carbohydrates 7g, Fat 12g (of which 1% saturated), Sodium 157mg. Each serving (3 ckies, 33g) contains 22mg of DHA and EPA (33% BDA) originating from an omega-3 rich oil, either from cold water fish or from algal extracts. In comparison, commercial diabetic sandwich ckies, marketed as designed to address the needs of diabetics, contain 2g/1g of fat, of which 25% are saturated and of course do not contain any additional proactive ingredients to lower the risk of diabetic related CVD or cognitive decline. A "regular" version of sandwich ckies contains only slightly higher levels of fat (22g/1g) and actually lower levels of saturated fat (18% of the total fat). Example 18; Bitter sweet chocolate with statins Hie bitter sweet chocolate of the invention is designed primarily for the diabetic and pre-diabetic populations and includes no sugar, has a relatively low fat content as to not contribute to the hypertriglyceridemia and/or hypercholesterolemia associated with diabetic conditions. Furthermore, the chocolate is fortified with statins for promoting the lowering of total and LDL cholesterol, which are important CVD risk factors. Ingredients: maltitol, cocoa mass, cocoa butter, eraulsifiers, flavors, statins. Nutritional values (lg): Protein 5g, Carbohydrates 61g, Fat 25g (of which 4% saturated), Sodium 8mg. Each serving (2g) contains a low dosage of statins, such as Pravastatin or Lovastatin, for example 2.5mg/serving, to maintain a lowering of cholesterol effect. Higher doses of the statins can be delivered in said fd product in case the number or variety of diabetics' fds delivering such active ingredients is very low and/or limited. In comparison, commercial diabetic bitter sweet chocolate, marketed as designed to address the needs of diabetics, contain 31g/1g of fat, of which 61% are saturated and of course do not contain any additional proactive ingredients to lower the risk of diabetic related CVD. A "regular" version of bittersweet chocolate contains actually slightly lower levels of fat (28g/1g) and similar levels of saturated fat (6% of the total fat). 14; Chocolate spread with canola oil and polyphenols The chocolate spread of the invention is designed primarily for the diabetic and pre-diabetic populations and includes no sugar, has a relatively low fat content as to not contribute to the hypertriglyceridemia and/or hypercholesterolemia associated with diabetic conditions. Furthermore, the chocolate spread's fat fraction utilizes primarily canola oil, characterized in high levels of unsaturated fatty acids and is further fortified with polyphenols characterized in strong antioxidation activity for fighting CVD risk factors. As seen in Example 1, the mere utilization of unsaturated fats and oils (HMUFA in this case) as the major fat of the diet is not sufficient to promote a significant improvement in CVD risk factors, such as total cholesterol, non-HDL cholesterol, and total cholesterol/HDL ratio, and hence additional proactive agents are necessary in order to exhibit lowering of the risk. Ingredients: maltitol, vegetable oils and fats (mainly canola oil), hazelnuts, soy flour, inulin (dietary fiber), cocoa powder, soy lecithin (emulsifier), flavors, polyphenols antioxidants (grape extract). Nutritional values (lg): Protein 6g, Carbohydrates 49g, Fat 2g (of which 1% saturated), Sodium Img. Each serving (25g) contains 7mg of polyphenols antioxidants such as grape extract, pomegranate extract, olive hydroxytyrosol, etc. In comparison, commercial diabetic chocolate spread, marketed as designed to address the needs of diabetics, contain 38g/1g of fat, and of course do not contain any additional proactive ingredients to lower the risk of diabetic related CVD. The "regular" version of a chocolate spread contains actually lower levels of fat (25.5g/1g). Example 15; Chocolate flavored wafers with soy proteins and phytosterols The chocolate flavored wafers of the invention are designed primarily for the diabetic and pre-diabetic populations and include no sugar, has a relatively low fat content as to not contribute to the hypertriglyceridemia and/or hypercholesterolemia associated with diabetic conditions. Furthermore, the wafers are fortified with soy proteins and wd phytosterols, synergistically contributing to balanced bld lipid profiles and reduce the risk of CVD. Ingredients: maltitol, vegetable oils and fats, wheat flour, soy flour, cocoa powder, emulsifier (lecithin}, flavors, salt, leavening agents, baking improver (protease), soy proteins isolate, wd phytosterols. Nutritional values (lg): Protein 6g, Carbohydrates 66g, Fat 15g (of which 18% saturated), Sodium 6mg. Each serving (4 wafers) contains lmg of wd phytosterols (12.5% RDA) and 2.5g of soy proteins (1% RDA). These levels of active ingredients are possible when a variety of fd products supply these ingredients through the daily nutrition. In comparison, commercial diabetic chocolate flavored wafers, marketed as designed to address the needs of diabetics, contain 36g/1g of fat, of which 82% (!!!) are saturated and of course do not contain any additional proactive ingredients to lower the risk of diabetic related CVD. A "regular" version of chocolate flavored wafers actually contains lower levels of fat (18.4g/1g) and actually lower levels of saturated fat (28% of the total fat). Exapaple 1.6; Canola oil low fat vanilla chocolate ice cream and soy proteins The low fat vanilla chocolate ice cream of the invention is designed primarily for the diabetic and pre-diahetic populations and include no sugar, has a low fat content as to not contribute to the hypertriglyceridemia and/or hypercholesterolemia associated with diabetic conditions. Furthermore, the ice cream's fat fraction is mainly composed of an unsaturated vegetable oil, such as canola oiL The ice cream is further fortified with soy proteins, the latter contributing to balanced bld lipid profiles and reduces the risk of CVD. Ingredients: milk, milk solids, polydextrose, maltitol, inulin (dietary fiber), cocoa powder, glycerol, vegetable oils, emulsifiers, stabilizer's, flavors, sweeteners (Acesulfam K, eucralose), soy proteins. Nutritional values (lg): Protein lOg, Carbohydrates 12.8g, Fat 1.5g (of which 2% saturated), Fibers 5g, Sodium 7mg, Calcium 114mg. Each serving (15g) contains 13.2g of soy proteins (5% RDA). In comparison, commercial diabetic ice cream, marketed as designed to address the needs of diabetics, contain only 1.5g/1g of fat, of which 74% (!!!) are saturated and of course do not contain any additional proactive ingredients to lower the risk of diabetic related CVD. Example 17; Yoghurt drink with phosphatidylserine The fruit flavored yoghurt drink of the invention is designed primarily for the diabetic and pre-diabetic populations and it includes no sugar, has a low fat content as to not contribute to the hypertriglyceridemia and/or hypercholesterolemia associated with diabetic conditions. Furthermore, the yoghurt drink is fortified with phosphatidyleerine, providing 1% of its minimal recommended daily dose, in order to further protect against cognitive decline or to address different stages of cognitive decline. Ingredients: pasteurized milk, maltitol, fruit puree/concentrate, milk powder, processed starches (E1422,11442), natural stabilizer (E44), flavor agents, citric acid, phosphatidylserine. Nutritional values (1ml): Protein 3.1g, Carbohydrates 16.4g, Fat 1.5g (1.18g milk fat, .32g soy phytosterols), Calcium HOmg, Sodium 76 mg. Each 25ml serving contains lmg of soybean derived phosphatidylserine (1% of the minimal recommended dairy dose). Example 18; A functional chocolate bar for diabetics The bar is a chocolate flavor functional bar, which provides 5% of the dailyrecommended dose of phytosterol-esters. The bar includes a combination of phytosterol esters and DAG dissolved in canola oil (Preparation A). Said combination includes 7%wt of phytosterol esters and about 8%wt of DAG with a total fatty acid profile of Canola oil. Typical composition of bar: Combination of phytosterol esters and DAG (about Ig), (Preparation A). Sugar Alcohols (Maltitol, Maltitol Syrup), Soy Protein Isolate, Dietary fibers (Inulin, Polydextrose), Canola oil, Cocoa Powder, Cocoa Butter, Cocoa mass, Sweeteners (Sucralose), Emulsifiers, Flavourings. The total weight of each bar is 5 g. We claim: 1. A food product having a low glucose content of 0 to 5% glucose and a balanced fat content of less than 10%, comprising a mixture of one or more of phytosterol esters and phytostanol esters (PS-E) with 1,3-diacylglycerides (DAG) optionally dispersed or dissolved in an edible oil or fat wherein the PS-E content is higher than the DAG content, for reducing insulin resistance in an obese subject with metabolic imbalances or in an individual prone to develop diabetes; and for preventing progression of insulin resistance in an obese subject prone to develop diabetes. 2. A food product as claimed in claim 1, wherein said metabolic imbalance is diabetes. 3. A food product as claimed in any one of claims 1 and 2, wherein the glucose content is 0 to 0.5%. 4. A food product as claimed in any one of claims 1 to 3, being glucose free. 5. A food product as claimed in any one of claims 1 to 4, wherein the fat content consists of saturated fats at less than 25% of the total fats. 6. A food product as claimed in claim 5, wherein the fat content consists of saturated fats at less than 10% of the total fats. 7. A food product as claimed in any one of claims 1 to 6, optionally comprising omega-3 fatty acids. 8. A food product as claimed in claim 7, wherein the omega-3 fatty acids are one or more of long-chain polyunsaturated fatty acids (LC-PUFA) and polyunsaturated fatty acids (PUFA). 9. A food product as claimed in claim 8, wherein the PUFA is alpha-linolenic acid. 10. A food product as claimed in any one of claims 1 to 9, wherein said product is provided with an anti-oxidant. 11. A food product as claimed in claim 10, wherein said antioxidant is a vitamin. 12. A food product as claimed in claim 11, wherein said vitamin is any one of vitamin C, Vitamin E, tocopherols, coenzyme Q10 and beta-carotene. 13. A food product as claimed in claim 10, wherein the anti-oxidant is any one of rosemary extract, lycopene, zeaxanthin, selenium, zinc and polyphenols. 14. A food product as claimed in claim 12, wherein said polyphenol is hydroxytyrosol. 15. A food product as claimed in any one of claims 1 to 14, wherein said product is optionally provided with a statin. 16. A food product as claimed in any one of claims 1 to 14, wherein said product is optionally provided with an ezitimibe. 17. A food product as claimed in any one of the preceding claims, wherein said food product is any one of dairy products, bakery products, condiments, beverages and drinks, snacks, candies, ice-creams and frozen desserts, morning cereals, nutrition bars, snack bars chocolate products, prepared foods, grain products and pasta, soups, sauces and dressings, confectionery products, oils and fats products, dairy and milk drinks, soy milk and soy dairy-like products, frozen food products, prepared meals and meal replacements, meat products, cheeses, yoghurts, breads and rolls, yeast products, cakes and cookies and crackers.

Documents:

1837-delnp-2007-abstract.pdf

1837-delnp-2007-assignment.pdf

1837-delnp-2007-Claims-(03-11-2010).pdf

1837-DELNP-2007-Claims-(08-03-2011).pdf

1837-delnp-2007-Claims-(18-09-2012).pdf

1837-DELNP-2007-Claims-(29-06-2011).pdf

1837-delnp-2007-claims.pdf

1837-delnp-2007-Correspondence Others-(01-07-2011).pdf

1837-DELNP-2007-Correspondence Others-(29-06-2011).pdf

1837-DELNP-2007-Correspondence Others-(30-06-2011).pdf

1837-delnp-2007-correspondence-others 1.pdf

1837-delnp-2007-Correspondence-Others-(03-11-2010).pdf

1837-DELNP-2007-Correspondence-Others-(08-03-2011).pdf

1837-delnp-2007-Correspondence-Others-(18-09-2012).pdf

1837-delnp-2007-correspondence-others.pdf

1837-delnp-2007-description (complete).pdf

1837-delnp-2007-drawings.pdf

1837-delnp-2007-form-1.pdf

1837-delnp-2007-form-18.pdf

1837-delnp-2007-form-2.pdf

1837-delnp-2007-Form-3-(01-07-2011).pdf

1837-delnp-2007-Form-3-(03-11-2010).pdf

1837-DELNP-2007-Form-3-(08-03-2011).pdf

1837-delnp-2007-form-3.pdf

1837-delnp-2007-form-5.pdf

1837-delnp-2007-GPA-(18-09-2012).pdf

1837-delnp-2007-pct-101.pdf

1837-delnp-2007-pct-210.pdf

1837-delnp-2007-pct-237.pdf

1837-delnp-2007-pct-304.pdf

1837-delnp-2007-pct-308.pdf

1837-delnp-2007-pct-373.pdf

1837-delnp-2007-Petition 137-(03-11-2010).pdf

1837-DELNP-2007-Petition 137-(08-03-2011).pdf

1837-delnp-2007-Petition 138-(03-11-2010).pdf

1837-DELNP-2007-Petition 138-(08-03-2011).pdf