How Diabatrol Works:

Diabatrol® is a natural nutraceutical medical food formulation comprised of FDA-USDA GRAS approved bioactive derivatives from whole grain which have been clinically documented to lower and stabilize blood glucose in type 2 diabetics and pre-diabetics. The sixty day clinical trials documented a 33% average reduction in Fasting Blood Glucose Levels and a 1.6 point reduction in average A1c levels in type 2 diabetics. The Diabatrol® formulation meets all regulatory compliances under DSHEA/FDA for all claims made, is hypoallergenic and gluten free.

Like many pharmaceuticals, the precise mode(s) of action for Diabatrol® have not been fully documented, but the system biology behind several nutraceutical components of the product have been documented and scientifically reported. The general mode of action in lowering and stabilizing blood glucose levels centers on Diabatrol’s® role in decreasing insulin resistance. There is medical consensus that insulin resistance is a root cause of type 2 diabetes. The American Association of Clinical Endocrinologist estimates that 90% of type 2 diabetics are insulin resistance. Two well studied ‘triggering mechanisms’ for insulin resistance include:

1.) Elevated Fatty Acids

Elevated fatty acids inhibiting insulin signaling and glucose uptake by interfering with the translocation of the glucose transporter, GLUT-4. Numerous scientific reports demonstrate that oversupply of lipids raises the circulating level of free fatty acid (FFA) and contributes to the development of type 2 diabetes (Diabetes 46 1997; Diabetes 50 2001; Banting Lecture; Diabetes 51 2001). Increase in plasma lipid levels impairs insulin activity, increase in plasma FFA reduces insulin-stimulated glucose uptake, whereas a decrease in lipid content improves insulin activity in the skeletal muscle cells, adipocytes and liver (Nature 414 2001).

2.) Oxidative Stress

Oxidative stress disrupting mitochondrial signaling and producing cellular insulin resistance (Nature 440 2006). Many biochemical pathways strictly associated with high blood glucose levels can increase the production of free radicals (Clin Chemistry & Lab Med 39 2001; Acta: Hung. J. Phys. 85 1997; Scand J. Clin & Lab Invest 59 1999). Prolonged oxidative stress in muscle and fat has been shown to significantly reduce insulin-stimulated glucose transport (J. Biol. Chem. 272 1997; Am. J. Physiol. 35 1997). In further support of the pathological role of oxidative stress, many of the adverse effects of high glucose on endothelial function, such as reduced endothelial-dependent relaxation and delayed cell replication, are reversed by anti-oxidants in vivo (J. Clin. Invest. 97 1996; Diabetes Care 25 2002).

Scientific research, in both animal and human subjects, generally concludes that there are multiple enzymatic and metabolic actions that play interactive roles in reducing insulin resistance, thereby helping improve blood glucose metabolism, reducing blood glucose and serum insulin levels, and therein reducing the health risks associated with diabetes. Preliminary research concludes that this is also the case in Diabatrol®, as the bioactive nutraceutical derivatives in the Diabatrol® formulation interact in several ways to reduce insulin resistance, including:

• Direct effect on insulin resistance.

In animal studies, insulin levels decreased by up to 70% after taking an active ingredient extract embodied in Diabatrol® (J. Agric. Food Chem. 2006). The Insulin/Glucose ratio is a measure of insulin efficiency and an indicator of insulin resistance. In one study, the insulin/glucose ratio was decreased by 65% (J. Nutr. 2006). In other animal studies, plasma glucose levels were decreased 22 to 26% (J. Ag and Food Chemistry. 2000; Atherosclerosis. 1991). In other scientific research the amino acid Arginine has been found to increase insulin sensitivity and thereby reduce insulin resistance (Diabetes Care, 2001). The bioactive ingredients in Diabatrol® contain biologically significant levels of Arginine.

Certain bioactive nutritional components have been documented to aid blood glucose stabilization:

• Antioxidant Activity

Diabatrol® contains very high levels of a number of natural polyphenols. These polyphenols have been found to have significantly higher antioxidant capacity than traditional supplemental vitamins (Vitamin E, C, etc.). In particular, Diabatrol® is high in natural tocotrienols, ferulic acid, gamma-oryzanols, inositol and several phytosterols. These antioxidants, in combination with over 80 additional natural antioxidants from the bioactive whole grain derivatives in Diabatrol®, have been clinically documented to play a synergistic role in reducing insulin resistance, blood glucose levels and serum lipid parameters in human subjects with diabetes (J. Nutritional Biochemistry, 2002; J. Ag and Food Chemistry, 2001).

• Tocotrienols

Independent laboratory analyses have documented the high natural antioxidant levels found in Diabatrol’s® bioactive ingredients (USDA, J of Ag and Food Chemistry, 2004; Brunswick Lab ORAC Test Values, 2007). Vitamin E is known to have eight homologues that are active in glucose metabolism, four each of tocopherols and tocotrienols. The primary bioactive function of the tocotrienol complex is its capacity as an antioxidant in improved cellular function and protection of the lipid cell membrane, thereby promoting healthy cellular function and more balanced blood glucose metabolism. Findings indicate that α-tocotrienol [contained in Diabatrol®] is at least 3-fold more efficient as a scavenger of peroxyl radicals than conventional vitamin E [α-tocopherol] (Nutrition, Lipids, Health, and Disease. 1995; pp 8-35). Diabatrol® contains significant levels of natural tocotrienols. In addition, scientific studies have further reported that these tocotrienols have been scientifically documented to lower total cholesterol and LDL cholesterol in blood plasma (Am. J. of Nutrition, 1991). Studies suggest that this is accomplished by inhibiting the activity of the enzyme HMG-CoA which is responsible for cholesterol synthesis in the liver (J. Bio. Chemistry, 1993). Micromolar amounts of tocotrienol, but not tocopherol, have been shown to suppress the activity of HMG-CoA (J. Med. Chem. 1992; J. Med. Chem. 1994). These findings provide insight into how lipid metabolism modification associated with Diabatrol’s® active ingredients affects blood glucose metabolism and cholesterol levels. The sixty day clinical trials of Diabatrol’s® active ingredients found an 8% reduction in LDL cholesterol.

• Gamma-Oryzanol

Diabatrol® contains very high levels of natural gamma-oryzanols. Scientific studies have confirmed that oryzanol is a natural antioxidant superior to tocopherols (J. Food Science Technology, 1993). The biologically active portion of gamma-oryzanol is ferulic acid. Recent findings in animal studies reported that ferulic acid significantly decreased the levels of glycogen in the liver and skeletal muscle along with diminishing the activities of hepatic glucose-6-phosphate dehydrogenase, catalase and peroxidase in when compared with controls (Methods Find Exp Clin Pharmacol 2008). In addition, gamma-oryzanol has been shown to affect bile acid secretion and fecal excretion of cholesterol (Atherosclerosis. 1989). In recent scientific studies it has been found that the active ingredients in Diabatrol® have reduced triglyceride and LDL levels 19.4% and 8% respectively. These reductions were found to be statistically significant (J of Ag and Food Chemistry, 2000).

• Magnesium

Diabatrol’s® natural ingredients are high in magnesium, which has been scientifically documented to play a supporting role in regulating blood glucose levels (White Paper, American Journal of Clinical Nutrition, 1987; Diabetes Care, 2003. An American Diabetes Association ‘Expert Panel’ concluded that magnesium may play an important role in reducing insulin resistance. Clinical researchers also have found an association between low magnesium levels and insulin resistance in type 2 diabetics (Diabetes Care, 1998).

• Chromium and Selenium

Chromium Picolinate (a naturally occurring amino acid metabolite) and Selenium are both contained in Diabatrol’s® natural formulation. Chromium has been documented to play a role in balanced glucose metabolism, mitigating what is sometimes referred to as the glucose tolerance factor (Dietary Chromium Overview, 2006). This essential mineral functions to help stabilize blood glucose levels through proper insulin utilization within the cells, enabling the insulin to enter the cell more readily. The principal function of Selenium is to inhibit the oxidation of lipids as a component of the enzyme glutathione peroxidase. It is a vital antioxidant, particularly in synergism with tocotrienols, and helps protect the body’s immune system by preventing the formation of free radicals.

• Fiber

Diabatrol® is high in dietary fiber, providing 4 grams per serving and 8 grams in a daily dose (two water soluble packets daily). Dietary fiber has been found to lower free fatty acid levels in human subjects, thereby playing an important role in helping to decrease insulin resistance (J. Nutritional Biochemistry, 2002). Moreover fiber has been shown to balance the rate of nutrient absorption. This balanced absorption helps the digestive system manage the secretion of intestinal hormones that play an important role in glucose metabolism and increasing insulin sensitivity (American Jour. Clinical Nutrition). The bioactive ingredients embodied in the fiber derivative portion of Diabatrol’s® proprietary formulation help manage glucose metabolism.