2.   Diabetic Mellitus Type 2 formula Objectives Overview - Key Objectives

• Provide a beneficial formula for the benefit Diabetic Mellitus Type 2 sufferers.
• Provide superior nutrients that help alleviate Diabetes Mellitus Type 2
• Provide proven nutrients that help regulate blood sugar
• Provide a unique formula with nutrients that are proven more effective
• Provide nutrients that deliver potent antioxidant activity
• Provide dietary guidelines that provide additional support for Type 2 sufferers.
• Provide nutrients that help protect against harmful lipid peroxidation.
• Provide a formula that improves the body's metabolism of glucose
• Provide a diabetic Type 2 formula that can be sold as OTC.
• The formula will be using the advanced Food State Nutrient technology

3.   The formula structure consists of the following 12 nutrients that provide

• Antioxidants – Vitamins: vitamins C, E, D and Bioflavonoids
• Antioxidant – Minerals: GTF Chromium, Zinc, Selenium, Vanadium
• Antioxidant – Additional: Beta Glucans

4.   Direct anti-diabetic formula nutrients

• Vitamin B3
• Vitamin C
• Vitamin D
• GTF Chromium
• Magnesium
• Selenium
• Zinc

5.   Specific additional anti-diabetic formula nutrients

• Vitamin E
• Biotin (part of the vitamin B group)
• Copper
• Bioflavonoids

6.   Clinical and Scientific Studies (peer-reviewed and published)

Over 50 studies have been carried out on Food State (Grow Company) nutrients over the years, many of which have been peer-reviewed. The main outcome of all of these studies has been to demonstrate that Food State is more bioavailable and better absorbed than isolated chemical nutrients.

This is because they are in a recognisable food form in a complex of proteins, lipids, carbohydrates and important additional co-factors. They are absorbed as easily as food in the body and the nutrients are delivered to sites of need. Ease of absorption in a food form is at the heart of good nutrition.

These Food State targeted protein/peptides vitamins and minerals have been successfully utilised to deliver nutrients to specific sites.

Science supports the chaperon proteins (and other co-factors) targeted delivery within the body using Food State Nutrients.

Specific studies for diabetes support the nutrients in the formula which are proprietary. The studies show the superior efficacy and benefits of these unique food structure nutrients.

7.   Key health issues associate with Diabetic Mellitus Type 2

The formula specifically provides nutrients that are proven to help:

• Regulate blood sugar levels.
• Retard the development of diabetic nephropathy
• Lower elevated sorbitol levels
• Lower elevated serum triglycerides levels
• Lower total serum cholesterol levels.
• Lower undesirable LDL cholesterol levels
• Increase desirable HDL cholesterol levels.
• Prevent and retard the progression cataracts
• Facilitate weight loss for person overweight
• Protect against heart disease.
• 6.7% of persons aged 20 - 29 have insulin resistance*
• Over 40% of persons aged 60 - 70 have insulin resistance*
• The World Health Organisation reports that over 180 million people have Diabetes Type 2.
• There are currently more than 194 million people with diabetes worldwide, according to the International Diabetes Federation, and this number could reach 333 million by 2025.
• In the USA, Diabetes Mellitus is the sixth most common cause of death
• The incidence of Diabetes Mellitus Type 2 has tripled during the period 1984-1999.
• Diabetes Mellitus Type 2 accounts for 90% to 95% of cases of Diabetes Mellitus.

*The figures above are perhaps a little out of date; they are none the less significant:

8.      Additional support

• A general dietary intake guide for both Diabetes Type 2 and 1 to help them manage their own process better with factual dietary knowledge.
• Scientific support with additional written clinical information for health professionals.
• A rationale of the nutrient ingredients and health benefits.

9. Food State Nutrients – the difference

Food State nutrients are different to 98% of the supplements on the market today. Food State nutrients have proven superior biological activity within the body. Clinical trials (published) have shown them to be more effective in comparison with traditional supplements. Food State supplements are the product of a propriety process that supplies a Food nutrient that is recognised within the body as a food and utilised more effectively.

Food State active nutrients are ‘chaperoned’ by the necessary protein/peptides transporters and additional co-factors which improve uptake of vitamin and mineral nutrients in the small intestine.

Due to the Food State nutrients superior effectiveness the targeted delivery allows decreases in the dose of ingredients-more at the levels found in natural foods. This is due to recognition within the body of the chaperoned protein/peptides and additional co-factors. These clinical benefits apply to all the Food State nutrients.

Protein Transporters

The importance of proteins in transporting nutrients efficiently round the body

Three articles concerning the 1999 Nobel Prize winner for Medicine, Dr. Günter Blobel demonstrate his identification of intrinsic signals on proteins that govern their transport and localisation in the cell.

This is something we have been saying for many years and now there is proof that the human body uses proteins like the address on an envelope.

Only the full address can deliver the message or nutrient to exactly the right place. Food State nutrients are transported to the site where they are needed via proteins; recognition of this process again supports the Food State concept.

Food State nutrients work in synergy as food complexes; this is not the case with the traditional chemical supplements. The chemical forms of supplements are often referred to as ‘natural’, which legally they can be called.

However, these chemical forms are not in a form that the body can recognise and often the actual uptake is around 10%. Of course this also implies that the body needs energy to try to eliminate the remaining non-usable parts of these chemical structures.

Traditional ‘free state’ chemical substances (often called ‘natural’)

Most supplements are in a highly refined chemically isolated form that is far removed from their natural state.

These traditional types of supplements are isolated fractions, and they lack the vital carrier food factors (protein, specific carbohydrates, beneficial lipids and a host of associated co-factors necessary for the nutrients to be delivered properly and effectively.

It is to be remembered that these chemical isolates will produce undesirable side effects which are not talked about but are prejudicial to good health and to the healing process. See Appendix 3

10. Formula Nutrient Rationale for Diabetes Mellitus Type 2 Sufferers

Vitamin B3

Vitamin B3 is an important member of the vitamin B group of beneficial substances. It has been shown to protect the beta cells (responsible for insulin production) and to retard the development of the diabetic nephropathy. It has also been shown to both lower and stabilise elevated blood sugar.

Vitamin B3 was found to prolong the ‘life’ of beta cells, protecting them from destruction and in doing so retarding their potential to change into the insulin-dependant Diabetes Type 1.

Vitamin B3 has been shown to lower total cholesterol levels. Undesirably high levels of LDL cholesterol are lowered with adequate Vitamin B3, and levels of the more desirable HDL cholesterol are increased.

Polyuria (frequent night time need for urination) was also found to normalise following supplemental vitamin B3.

Note Biotin and Vitamin B12 enhance the use of vitamin B3 within the body.

Vitamin C

Diabetes Mellitus Type 2 sufferers are often deficient in Vitamin C. Insulin facilitates the transport of vitamin C into cells and the insulin resistance that afflicts diabetes mellitus sufferers can impair the transport of vitamin C into cells. Vitamin C helps to prevent insulin resistance by lowering blood sugar levels. It also helps to lower elevated blood sugar.

The Food State Vitamin C has antioxidant properties and has been shown to reduce the potential and actual experience of Galactose cataracts of the eye. Research has shown that the rate of reversal of these cataracts is up to 70%.

Vitamin C helps the body use cholesterol, and this proper function assists in lowering total cholesterol levels. In addition, this vitamin reduces the undesirable LDL cholesterols and increases the desirable HDL cholesterol levels.

Vitamin C counteracts and can destroy many harmful free radicals, while protecting some important beneficial fats. Inappropriate intake of dietary fat is directly linked with increases of harmful free radicals.

The name Vitamin C is mainly associated with the substance known as ascorbic acid. This is normally in a supplement in the form of a synthetically manufactured chemical ‘isolate’. This means that it is not easily recognised by the body and not well utilised. Food State Vitamin C is not an isolated chemical but a Food Matrix containing the necessary proteins and co-factors to ensure efficient delivery of the nutrient.

Vitamin D

Vitamin D is an antioxidant and especially protective against the destruction of beneficial fats. It also helps to lower elevated blood sugar levels, is protective to the heart, and helps to prevent insulin resistance

Vitamin D deficiency is linked with an increased risk of Diabetes Type 2. Over sixty percent of Type 2 sufferers were found to be deficient. This vitamin is required by the beta cells of the pancreas and a deficiency can result in an impairment of insulin secretion.

An optimum level of Vitamin D has been shown to be beneficial with regard to the cardiovascular system, helping to prevent cardiovascular diseases. In part, this cardiac support is through the action of Vitamin D in lowering elevated blood pressure and reducing hypertension.

Both obesity and insulin resistance are involved with an increased risk of hypertension. Medical journals have stated that over 70% of Diabetes Type 2 patients have hypertension

Clinical studies found that a low concentration of Vitamin D related to the prevalence of cardiovascular disease among Type 2 diabetic patients.

Note Men generally have been found to have higher Vitamin D concentrations than women. The results showed a reduced risk of Type 2 diabetes for men with optimum Vitamin D status.

Vitamin E

Vitamin E possesses antioxidant properties and has been shown to increase insulin sensitivity and help prevent Diabetes Mellitus Type 2. Epidemiological evidence has shown that low Vitamin E intake increased the risk of developing Diabetes Type Two.

Vitamin E has been shown to positively counteract insulin resistance (i.e. its actions can increase insulin sensitivity) in both elderly and younger diabetes mellitus sufferers. . Vitamin E has also been shown to help prevent and treat (diabetic) neuropathy.

Nerve conduction velocity in Diabetes Mellitus Type 2 sufferers is beneficially increased with adequate levels of vitamin E. This important vitamin helps reduce the harmful and toxic effects of lipid peroxidation.

Health complications associated with Diabetes Type 2 have been found to be exacerbated when vitamin E status is low.

Vitamin E both protects and neutralises harmful free radicals from oxidation; this is particularly important with regard to the inhibition from oxidation of LDL cholesterol

Biotin

Biotin is a member of the Vitamin B group of beneficial nutrients. It helps to regulate blood sugar levels through its role in ensuring proper utilisation of glucose within the liver, and therefore the proper secretion of insulin.

This complex process between the pancreas and liver requires adequate biotin.

Biotin can enhance the function of those digestive enzymes that are required to break down carbohydrates, fats, proteins and other nutrients for proper use by the metabolic processes of digestion.

Bioflavonoids

These are a special ‘family’ of nutrients found in plants and some fruits. They are known to enhance the beneficial actions of Vitamin C and help the body retain it for longer. They also help strengthen blood vessels and enhance some functions of the immune system.

Some of the beneficial substances in the bioflavonoid complex have been shown to reduce the undesirable LDL cholesterol levels and raise the beneficial HDL cholesterol levels.

Clinical studies found that compounds within the bioflavonoid complex helped both prevent and treat Diabetes Mellitus Type 2 through their action in helping to regulate blood sugar levels.

GTF Chromium

GTF Chromium specifically improves the body's metabolism of glucose. Chromium deficiency is an underlying cause of some cases of Diabetes Mellitus Type 2.

GTF Chromium specifically helps reduce Diabetes Mellitus Type 2, as it increases insulin sensitivity and normalises blood sugar levels.

The GTF Chromium works together with insulin to regulate blood sugar levels, lowering elevated levels and raising blood sugar levels when below normal.

Good cholesterol levels are important with regard both to Diabetes Type1 and Type 2. Research has shown that GTF Chromium can help lower total serum cholesterol levels by up to 25%. Importantly, GTF Chromium can increase the production of beneficial high density lipoproteins (HDLs) by up to 18%.

GTF Chromium also helps to decrease the undesirable low density lipids (LDL) Cholesterol levels by up to 18%.

GTF Chromium can help to prevent diabetic nephropathy and elevated blood pressure. Up to 20% of Diabetes Mellitus Type 2 patients develop diabetic nephropathy.

Calcium

The health benefits of an optimum intake of calcium towards Diabetes Mellitus Type 2 is proven. Calcium helps to regulate blood sugar fluctuations and stabilises the cell membranes.

One study of women with a high intake of calcium suggested calcium levels as a cause of hypertension (elevated blood sugar). Over 70% of all diabetic Type 2 sufferers in the USA experience hypertension.

Research has shown that optimum calcium intake does help reduce blood pressure, by helping to reduce the insulin requirement as well as some of the undesirable side effects, such as diabetic nephropathy and retinopathy.

This important mineral has been shown to help reduce imbalances within the pancreas among Diabetes Type 2 sufferers.

A study found that for women who took supplemental calcium reduced the risk of Diabetes Type 2 by almost 20%. It was also found that if the calcium was taken with Vitamin D there was a reduction of 33%.among Type 2 sufferers.

Both the calcium and Vitamin D were also found to significantly reduce the progression of women with Diabetes Type 2

In another study, calcium intake was surveyed within a group of American women. A six year follow-up showed that the women with an adequate calcium intake had a 30% lower risk of developing Diabetes Mellitus Type 2

In comparison with traditional calcium supplements, the Food State calcium (which is at a low dosage) demonstrated that the traditional form (calcium attached to a stabilising compound) lowered blood pressure in two weeks. However, blood pressure subsequently returned to, and remained at, the elevated position.

The Food State calcium is presented to the gut as a food, not a chemical, and consequently uptake is far greater. In the comparison study, the Food State calcium took about three weeks before a reduction in elevated blood pressure was found.

After two months, however, the study found that the chemical calcium supplement had no effect on blood pressure, which had returned to the levels prior to supplementation. The Food State calcium was found to have lowered elevated blood pressure by almost 15%, and this reduction continued as long as the calcium intake was maintained.

Optimum calcium, then, can reduce elevated blood pressure and help to prevent Diabetes Mellitus Type 2

Some of the side effects of the traditional calcium supplements (with stabilising chemicals) are a cause for concern. A high traditional calcium supplement intake is associated with the plaque in the arteries that is implicit in atherosclerosis. This form of supplementation is also associated with kidney stones, PMS, cystitis and abnormalities of bone formation.

Magnesium

Deficient levels of intracellular magnesium can contribute to the impaired insulin response that occurs in Diabetes Type 2.

Magnesium helps to prevent Diabetes Type 2 and to keep it under control. Most Diabetes Type 2 sufferers are prone to magnesium depletion.

A dietary deficiency or low intake of magnesium is associated with the formation of cataracts. Optimum magnesium is required for proper kidney function and to retard the development of kidney stones.

Hypertension is related to low magnesium in the cells and higher incidence of vascular disease. Optimum levels of magnesium in the red cell related directly to greater sensitivity to insulin.

With regard to magnesium and fats, clinical studies have shown that there is a significant fall in total cholesterol. The fall was associated with lower values of the undesirable LDL cholesterol and triglycerides and a rise in the beneficial HDL cholesterol levels after magnesium supplementation

Magnesium helps to prevent, and is valuable in the treatment of, several types of cardiovascular diseases. The heart requires this mineral for proper function and energy levels.

Magnesium is required by all cells of the body for proper function supplying energy for tissue repair and growth. Magnesium’s role in energy production is from its association as a co-factor for most of the enzymes needed for the production of the energy molecule adenosine triphosphate (ATP).

Selenium

Adequate selenium is required for the proper function of the pancreas. It is estimated that in the USA as many as 8 out of 10 persons are deficient in selenium, which is about the same as within the EU community. Research has shown that proper selenium intake is useful for the prevention and treatment of diabetic nephropathy.

Research with Diabetes Type 2 also demonstrated the beneficial effects of selenium supplementation, and more so of selenium combined with vitamin E, which together were associated with a protective effect on the kidneys

Selenium possesses antioxidant properties and has been demonstrated to help lower elevated blood sugar levels in Diabetes Type 2 sufferers.

Selenium is protective to the heart and can help prevent several types of cardiovascular diseases. It helps to lower harmful elevated levels of homocysteine, and elevated blood pressure.

Cataracts are associated with low selenium intake, and clinical data shows that adequate intake of this mineral can help treat and reverse this eye condition.

Note Selenium has been shown to help to prevent age-related macular degeneration (ARMD).

Zinc

Diabetes Type 2 sufferers are often found to be deficient in zinc. However, zinc supplementation has been shown to improve the situation of Type 2 sufferers. Supplementation has been shown to help in achieving a better glycemic control and improvement in severity of peripheral neuropathy

Zinc has antioxidant properties and is beneficial in the treatment of diabetic neuropathy. Researchers state that there is a clinical correlation between low zinc levels and insulin resistance, also stating that zinc deficiency could decrease the response to insulin.

Zinc and GTF Chromium work synergistically to the benefit of Type 2 sufferers. Research has shown that they both have a positive effect on insulin signalling, leading to glucose uptake. Regarding the proper function of the pancreas, zinc is required at optimum levels to facilitate the digestive function of the pancreas.

There are negative concerns about the role of both zinc and copper with regard to Diabetes Type 2,. relating to mineral overload of the non-protein-bound forms, which can generate various reactive oxygen species, damaging tissues or cells.

Copper

Copper deficiency is linked with elevated and undesirable LDL cholesterol. Studies have shown that with adequate supplementary copper these elevated levels are reduced.

A copper deficiency has also been shown to be associated with lower levels of beneficial HDL cholesterol. Diabetes Type 2 sufferers are often found to be deficient in copper.

Copper and zinc are required in a balanced ratio: a high intake of zinc can deplete copper, but in the correct ratio and form these two minerals work synergistically. Copper can be toxic if zinc is not present at the correct level to create the proper form and balance as found in real food.

The copper and zinc in the Food State form are not a concern as they do not antagonise each other. Both minerals are in a food form and not in the standard chemical supplement form that is ‘free’ for potentially negative interchange.

Carbohydrates intake is a sensitive dietary consideration for diabetic Type 2 sufferers, as a high intake can be a contributing factor to copper deficiency. Indeed, copper deficiency is also associated with a high intake of refined carbohydrates such as glucose, fructose and sucrose.

Taking garlic regularly can also be sensible, as certain of its components prevent copper from becoming an undesirable pro-oxidant. In addition, it provides many other benefits in relation to the maintenance of proper cholesterol balance.

What is Your ‘Natural’ Vitamin Really?

It may come as a surprise that most ‘natural’ vitamins in supplements are petroleum extracts, coal tar derivatives, and chemically processed sugar (plus sometimes industrially processed fish oils), with other undesirable acids and industrial chemicals (such as formaldehyde) used to process them. Synthetic vitamins were originally developed because they cost less.

Assuming the non-food product does not contain fish oils, most synthetic, petroleum-derived supplements will have their products called 'vegetarian', not because they are from plants, but because they are not from animals.

This table may help your future choices regarding supplementation.

Composition of Food and Non-Food ‘natural’ Vitamins

Yeast Concerns

Most people who have yeast allergies are sensitive to the proteins in the yeast wall membrane. The enzyme digestion process breaks down this membrane and there is no active yeast left in the Food State nutrients once it has finished. In fact, the whole yeast cell structure no longer exists, yet it retains all the vital nutritional components in an easily digestible form.

The Food State yeast grown nutrients have been used over many years in hospitals and clinics with yeast sensitive persons. There has never been an adverse reaction and indeed there will not be, as the allergens in the cell wall are removed at the end stage of the manufacturing process.

As stated above, the Food State nutrients are GROWN, not fermented. There is a very sound reason for drawing attention to this difference: as a result of yeast fermentation harmful substances occur, such as ethyl carbamate, a suspected carcinogen.