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Title: Chromium Picolinate Linked With Reduced Carbohydrate Cravings in People With Atypical Depression

"Chromium Picolinate Linked With Reduced Carbohydrate Cravings in People With Atypical Depression"

Severe Carbohydrate Cravers Experienced the Most Benefit from Chromium Picolinate Supplementation WHITE PLAINS, NY -- September 29, 2005 -- A randomized, double-blind, placebo-controlled study assessing chromium picolinate supplementation in 113 people with atypical depression found that a subset of patients who reported the highest levels of carbohydrate cravings demonstrated significantly greater reductions than the placebo group on four items on the Hamilton Depression Rating Scale (HAM-D-29): carbohydrate craving, appetite increase, increased eating, and diurnal variation of feeling (mood variation throughout the day). The study, published today in the Journal of Psychiatric Practice, found that 65% of the chromium picolinate patients with high carbohydrate craving versus 33% of those receiving placebo had significantly greater improvements on total HAM-D-29 scores (p < 0.05). HAM-D-29 is a standard tool commonly used in assessing severity of symptoms in depressed patients. Carbohydrate cravings, weight gain and unexplained fatigue are characteristic symptoms of atypical depression, a common but frequently undiagnosed depressive disorder affecting up to 42% of the 19 million Americans diagnosed with depression. "These results suggest that the use of chromium picolinate may be beneficial for patients with atypical depression who also have severe carbohydrate craving," said the study's lead investigator, John P. Docherty, MD, president and CEO of Comprehensive NeuroScience Inc, and adjunct professor of psychiatry at Weill Medical College of Cornell University. "For years, the link between depression, insulin sensitivity, and the value of dietary chromium picolinate has been hinted at in small studies and this trial may bring us closer to understanding the connection." Study Design The study, "A Double-Blind, Placebo-Controlled, Exploratory Trial of Chromium Picolinate in Atypical Depression: Effect of Carbohydrate Craving" was an 8 week, multi-center trial of 113 randomized adult outpatients with atypical depression. Patients ranged from age 18-65 years of age. The 110 patients constituting the intent-to-treat (ITT) population received 600 mcg/day of elemental chromium, as Chromax[^â chromium picolinate (n = 70) or placebo (n = 40).

This ITT group was defined as patients who received at least one dose of study medication and completed at least one study evaluation, while the evaluable population was the subset of 75 patients (n=50 chromium picolinate and 25 placebo) who took at least 80% of the study product with no significant protocol deviations. Primary efficacy measures were the 29-item Hamilton Depression Rating Scale and the Clinical Global Impressions Improvement Scale (CGI-I). Nutrition 21 (NASDAQ: NXXI) supplied Chromax (chromium picolinate) for the clinical trial.

Investigators found no significant difference between the chromium picolinate and placebo groups on overall improvement on the primary efficacy measures (both the placebo and treatment groups significantly improved from baseline).

However, the chromium picolinate group in the evaluable populations showed significantly greater improvements in four HAM-D-29 items: carbohydrate craving, appetite increase, increased eating, and diurnal variation of feeling. In addition, the chromium picolinate group reporting the highest levels of carbohydrate craving showed significantly greater improvements than the placebo group on overall HAM-D-29 scores.

These results held true for both the ITT group (65% chromium picolinate versus 33% placebo) and the evaluable group (80% chromium picolinate versus 38% placebo). The high carbohydrate cravers in the ITT population treated with chromium picolinate also showed significant improvement compared with placebo on three of the same HAM-D-29 items: carbohydrate craving, appetite increase and increased eating.

Chromium picolinate was well tolerated throughout the study and treatment-associated adverse events were minimal and not statistically or clinically different from those seen in the placebo group.

"These findings also suggest that physicians and mental health professionals should be alert to patients who report carbohydrate craving as it may signal the possible presence of a more serious underlying medical condition, such as atypical depression," Dr. Docherty said. "The use of antidepressants, mood stabilizers, and antipsychotics that are commonly prescribed to treat depression can often worsen carbohydrate cravings. A treatment that effectively reduces carbohydrate cravings and has a favorable tolerability and side-effect profile would be a very useful contribution to improve overall health outcomes."

Chromium is an essential trace mineral whose main function is to work with insulin to metabolize carbohydrates, fats and proteins. When chromium is bound to picolinic acid to create chromium picolinate, absorption in the body is significantly improved.

Recently the U.S. Food and Drug Administration recognized chromium picolinate as a safe nutritional supplement.

SOURCE: Comprehensive NeuroScience, Inc.

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