Results from Diachrome™ Clinical Trial Presented at American Heart Association (AHA) ATVB Conference
San Francisco, May 6, 2004 – (Nutrition 21, Inc. Nasdaq: NXXI) – Results of a new double-blind, placebo-controlled, randomized clinical study show that daily nutritional supplementation with a combination of chromium picolinate and biotin (marketed as Diachrome™) significantly improved coronary risk factors in people with type 2 diabetes. The clinical study, which evaluated 24 patients over 30 days, was presented today at the AHA’s Annual Conference on Arteriosclerosis, Thrombosis & Vascular Biology (ATVB) in San Francisco.
The study found the following significant improvements in subjects who added Diachrome, to their treatment regimen:
• Total cholesterol levels dropped an average of 19.1 mg/dL
• LDL (“bad”) cholesterol levels dropped an average of 10.9 mg/dL
• Average fasting blood glucose (FBG) levels decreased 26.2 mg/dL
• Apo-B dropped -5.3 mg/dl
• Ratio of apo-B/apo-A; LDL-C/HDL-C improved
“This study emphasizes that Diachrome not only improves blood sugar levels, but decreases LDL cholesterol which will help people with diabetes meet the ATP III guidelines for cholesterol which is difficult for them to achieve, “ states Jeffrey Geohas, MD, principal investigator, medical director, Radiant Research, Chicago. “Diachrome should be considered as an important adjunct therapy to statins and diet in lowering LDL cholesterol.”
All study subjects had type 2 diabetes for at least one year. They exhibited poorly controlled blood glucose levels, as measured by fasting blood glucose (FBG) above 200 mg/dL and elevated glycosylated hemoglobin (HbA1c) above 7%, despite taking anti-diabetic medications for at least six months. Subjects were divided into two groups to randomly receive either Diachrome or placebo daily, while continuing their prescription medications. The 30-day measurements also showed a decrease in average triglyceride levels, although it was not statistically significant.
“While Diachrome continues to show effectiveness in improving blood glucose levels for people with type 2 diabetes, evidence is also building as to positive effects on coronary risk factors,” explains Anne Daly, MS, RD, BC-ADM, CDE, author and expert in diabetes care and education. “These data indicate the need for further study into the potential for Diachrome to help prevent cardiovascular disease, which is the leading cause of diabetes-related death.”
Nutrition 21 commissioned the cohort study through Radiant Research. In addition, the Company is collaborating with XLHealth Systems, formerly known as Diabetex, in an ongoing clinical trial measuring blood glucose levels as well as multiple heart disease risk factors in more than 500 people with type 2 diabetes scheduled for completion at the end of 2004.
“We’re pleased to see these beneficial results in only 30 days that support the potential for Diachrome as a nutritional adjunct to diabetes therapy, “said Gail Montgomery, president & CEO, Nutrition 21. “As our research program nears completion we hope to conclusively demonstrate that Diachrome offers a safe, convenient and effective means of managing multiple risk factors associated with diabetes and lowering the cost of patient care.”
Diachrome is a patented nutritional supplement composed of Chromax® chromium picolinate and biotin. These two ingredients are both Generally Recognized as Safe (GRAS) for use as ingredients in food and supplements. Research indicates that chromium, in the form of chromium picolinate, enhances blood sugar control in people with insulin resistance and type 2 diabetes. Biotin, also known as vitamin H, has independently demonstrated glucose and lipid-reducing effects. Chromium is an essential mineral that is required for proper insulin function and metabolism.
About Nutrition 21
Nutrition 21 is a nutrition bioscience company, which develops and markets nutritional products, with health benefits substantiated by clinical research. The Company markets Chromax, the leading brand of chromium, and holds 35 patents for nutrition products, 22 for chromium compounds and their uses. For more information, consumers and health professionals, may visit www.nutrition21.com or www.diachrome.com or call 1-866-DIACHROME.
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