PURCHASE, NY, January 8, 2007 – Nutrition 21, Inc. (NASDAQ: NXXI) today announced the results of a recent placebo controlled, double-blind, randomized, single center study that demonstrated that Diachrome®, a patented combination of chromium picolinate and biotin, safely improves blood glucose levels and cholesterol metabolism in people with type 2 diabetes. Published in the December issue of Diabetes Technology and Therapeutics, the study supports the role of chromium picolinate – the most studied, highly absorbed and efficacious form of chromium – plus biotin as a safe and effective nutritional adjunct therapy in diabetes care.
The 30-day study examined thirty-six overweight or obese poorly controlled patients with type 2 diabetes taking Diachrome who were already receiving oral anti-diabetic drug(s). The results also showed a significantly greater reduction in the total area under the curve for glucose (AUCg) during the oral glucose tolerance test (OGTT) for the treatment group (mean change -9.7%) compared with the placebo group (mean change +5.1%). Mean fructosamine levels, a measure of the average blood glucose level during a period of three weeks, were also significantly reduced in the treatment group (-1.3 mmol/L) compared to the placebo group (0.7 mmol/L).
"Results from this pilot study promote the potential benefits of supplementing chromium picolinate and biotin with one's daily diabetes care regimen," said Gregory Singer, MD, lead author and cardiovascular medicine specialist at Yale University School of Medicine. "Chromium picolinate with biotin represents an adjunctive strategy to conventional oral diabetes therapy for improved blood sugar control and cholesterol metabolism."
A larger 400 patient, 90-day randomized placebo controlled study to determine the effects of chromium picolinate/biotin on hemoglobin A1c and other risk factors in type 2 diabetes is expected to be published next year.
"Previous studies have demonstrated that chromium picolinate can significantly impact A1c and other critical markers in people with type 2 diabetes," said Dr. Singer. "Additional research currently underway may provide us with further understanding of the supplement's role in the management of type 2 diabetes."
Another study released this month at the 19th World Diabetes Congress meeting in Cape Town, South Africa, demonstrated that supplementing with chromium picolinate, an active ingredient in Diachrome, led to significant improvements in blood sugar levels of people with type 2 diabetes over a six-year period. In addition to existing treatments, 1056 patients with diabetes ages 20 to 90 years old were observed among nine sites before and during supplementation with 500 mcg daily of chromium as chromium picolinate for one to six years. A significant decrease in fasting glucose levels of 4.67 mmol/L and postprandial glucose levels of 5.77 mmol/L was seen in patients taking chromium picolinate. The study showed that blood glucose levels continued to improve each year throughout the six years of the study.
"This study – one of the largest and longest clinical trials measuring chromium picolinate's effects on blood glucose levels – underscores the nutrition supplement's beneficial role in helping manage type 2 diabetes," said lead investigator Nancy Cheng, MD, PhD, Senior Director of Tang-An Diabetic Clinic and Education Center in Beijing.
Chromax® chromium picolinate, found in Diachrome and used in these studies, has been recognized as safe by many of the world's leading government and academic research institutions, including the U.S. Food & Drug Administration, the Institute of Medicine and the UK's Food Standards Agency. In addition, biotin has been deemed safe by the Food and Drug Administration and is also Generally Recognized as Safe (GRAS) for use in foods and supplements.
About Diachrome
Diachrome is a non-prescription nutrient-based therapy formulated to help support blood glucose management in people with diabetes. It is composed of two safe and beneficial nutrients: chromium (as Chromax® chromium picolinate) and biotin (a B-vitamin). A growing body of scientific evidence indicates that Diachrome's unique ingredient combination has positive effects on insulin function, blood glucose, lipid metabolism and cardiovascular health. The nutritional therapy can be found in retail stores nationwide.
About Nutrition 21
Nutrition 21 is a nutritional bioscience company and the maker of chromium-based and omega-3 fish oil-based supplements with health benefits substantiated by clinical research. The company markets Chromax® chromium picolinate, http://www.chromax.com/, which is the most-studied form of the essential mineral chromium. Chromax, a supplement for healthy and pre-diabetic people that promotes insulin health and helps improve blood sugar metabolism, cardiovascular disease, control carbohydrate cravings and fight weight gain, is now available through food, drug and mass retailers nationwide. Nutrition 21 also developed and markets Diachrome®, http://www.diachrome.com/ , a proprietary, non-prescription, insulin sensitizer for people with type 2 diabetes. It is available in select drug retailers nationwide. Nutrition 21 holds 33 patents for nutrition products and uses, 23 of which are for chromium compounds and their uses. The Company is the exclusive importer of Icelandic fish oils, including omega-3 fatty acids, which are manufactured to pharmaceutical standards and sold under the Iceland Health® brand, http://www.icelandhealth.info. More information is available at http://www.nutrition21.com.
Journal
Diabetes Technology & Therapeutics