Results of Human Clinical Trial Reported at National Institutes of
Mental Health New Clinical Drug Evaluation Unit Conference
PHOENIX, AZ, June 2, 2004, – (Nutrition 21, Inc. Nasdaq: NXXI) – Results of a new double-blind, placebo-controlled human clinical trial found that daily supplementation with chromium picolinate significantly reduced some key symptoms of atypical depression. People who reported high levels of carbohydrate cravings experienced significant decrease in their carbohydrate cravings and depression in response to chromium picolinate. Also, there was no difference in side effects in patients treated with chromium picolinate compared to those treated with the placebo. Atypical depression is a common, but frequently undiagnosed, form of depression affecting up to 40 million Americans. The new evidence was presented today at a conference of the National Institutes of Mental Health (NIMH) New Clinical Drug Evaluation Unit (NCDEU) in Phoenix, Arizona.
Atypical depression is a major depressive disorder characterized by a distinct combination of symptoms that include mood swings, carbohydrate cravings, weight gain, rejection sensitivity and lethargy.
“This is the first indication that chromium piconlinate may play an important role in the reduction of carbohydrate cravings in people with atypical depression,” explains John Docherty, MD, President, Chief Executive Officer of Comprehensive NeuroScience, Inc. (CNS), principal investigator of the study. “It also may offer a new treatment option for atypical depressed patients with carbohydrate cravings who find it difficult to stay on current prescription medication because of the common side effects of sexual dysfunction and weight gain.”
The multi-center study of 113 patients found that daily supplementation with 600 mcg of chromium as chromium picolinate, significantly reduced carbohydrate cravings compared to placebo, and improved other symptoms such as mood swings, fatigue and weight gain perception. The results also show that people with the highest levels of carbohydrate cravings had the most significant reduction in depressive symptoms. “The study suggests that carbohydrate cravings may be a key and independent marker of atypical depression and might predict how patients will respond to chromium picolinate therapy,” added Docherty.
The research builds on beneficial effects of chromium picolinate reported in a recent pilot study published in the Journal of Biological Psychiatry. The study was conducted at the Duke University Medical Center Department of Psychiatry and Behavioral Sciences.
“We’ve seen remarkable improvements in depressed patients after supplementing with chromium picolinate,” says Malcolm McLeod, MD, a practicing psychiatrist, who collaborated on the Duke University study. “Chromium picolinate is a real breakthrough in providing safe and simple relief of atypical depression symptoms, many of which currently go untreated.”
Researchers hypothesize that chromium’s essential role in insulin function may be the 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 nutritional supplementation with chromium, in the form of chromium picolinate, helps improve insulin insensitivity and diabetes.
According to the National Institutes of Mental Health, an estimated 22.1 percent of Americans ages 18 and older—about 1 in 5 adults—suffer from a diagnosable mental disorder in a given year. This figure translates to approximately 44.3 million people. “These findings broaden the potential applications for patented uses of chromium picolinate as an adjuvant nutritional therapy for depressed populations, a major health market that is growing significantly,” said Gail Montgomery, President and CEO of Nutrition 21, which commissioned the study. Additional data on chromium picolinate and carbohydrate cravings in atypical depression will be presented at the Collegium Internationale Neuro- Psychopharmacologium (CINP) in Paris in late June.
About Nutrition 21
Chromax chromium picolinate, which is the most studied form of nutritional chromium, was used in the studies. Nutrition 21, Inc. is a bioscience firm that develops chromium-based nutritional products, which are supported by clinical research. The company markets Chromax, the leading brand of chromium, and holds 35 patents for nutrition products, and 22 patents for chromium compounds and their uses. For more information, visit www.nutrition21.com
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