Clinical Trial Linking Anti-Depressant Response To Carbohydrate Cravings
Reported to International Experts at CINP Congress
Paris, France June 21, 2004--( Nutrition 21, Inc. (Nasdaq: NXXI) ) A new double-blind, placebo-controlled clinical trial in 113 patients diagnosed with atypical depression found that daily supplementation with chromium picolinate had significant anti-depressant effects in a patient sub-group with high levels of carbohydrate cravings. Subjects with the highest levels of carbohydrate cravings at baseline experienced the most significant clinical response to the chromium picolinate. The results of the 8-week, multi-center study were presented today at the 24th International Neuropsycho-pharmacology Congress (CINP) in Paris (www.cinp2004.com).
Carbohydrate cravings, weight gain and unexplained fatigue are hallmark symptoms of atypical depression, a common, but frequently undiagnosed, depressive disorder estimated to affect as many as one-third of depressed patients. According to a 1990 World Health Organization study, depression is ranked as the fourth most deadly disease worldwide and is expected to be second only to heart disease by 2020.
"The results suggest chromium picolinate may offer a new treatment option for atypical depressed patients who find it difficult to stay on current prescription medication because of common, but often intolerable side effects, such as sexual dysfunction and weight gain,"explains John Docherty, MD, President, Chief Executive Officer of Comprehensive NeuroScience, Inc. (CNS), principal investigator of the study. "These findings also offer health professionals potential insight into determining the most effective treatment for depressed patients."
The new study also found that nutritional supplementation with chromium in the form of chromium picolinate significantly improved carbohydrate cravings, in addition to other distinct symptoms of atypical depression. There is currently no recognized treatment for carbohydrate cravings.
Other data from the study were released at a U.S. National Institutes of Mental Health (NIMH) conference last week in Phoenix, Arizona, and builds on beneficial effects of chromium picolinate reported in a recent pilot study published in the Journal of Biological Psychiatry.
Researchers hypothesize that chromium's essential role as an insulin co-factor may be the biological link between chromium, carbohydrate cravings and atypical depression. Insulin has effects on metabolic function that may impact serotonin levels in the brain. Impaired insulin function, which leads to poor glycemic control, is linked to a number of health conditions including diabetes, where the increased incidence of depression is two times greater than in normal populations. Numerous clinical studies show that supplementation with chromium, in the form of chromium picolinate, is safe and helps improve insulin insensitivity and diabetes.
"Nutrition 21 is working with US and European authorities and clinicians to provide the most comprehensive research available on the safety, efficacy and affordability of chromium picolinate in treating diseases linked to insulin resistance. We plan to submit a petition for regulatory approval in Europe in fiscal 2005," stated Gail Montgomery, President and CEO, Nutrition 21, Inc. which commissioned the study.
Commercially available Chromax® Chromium Picolinate, which has been affirmed as safe for use in foods in the US (GRAS), was used in the study. The safety of Chromax Chromium Picolinate was further confirmed in a recent review published in the June 2004 issue of Food and Chemical Toxicology.
About Nutrition 21
Chromax is the most researched form of nutritional chromium, used in dozens of scientific studies. Nutrition 21 is a bioscience company that researches, develops and markets chromium-based nutrition products, with safety and health benefits supported by quality scientific research. For more information visit www.nutrition21.com.
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