New NIH-Funded Pilot Study Indicates Chromium Picolinate Supplementation May be an Effective Treatment for Polycystic Ovarian Syndrome -PCOS-.

Business Editors/Health/Medical Writers

SAN ANTONIO--(BUSINESS WIRE)--Oct. 15, 2003

Promising Nutritional Therapy for 2 Million American Women Presented at American Society for Reproductive Medicine Conference (ASRM)

(Nutrition 21, Inc., Nasdaq:NXXI) -- Results of a new pilot study funded by the National Institutes of Health (NIH) showed that daily supplementation with 1,000 mcg of chromium as chromium picolinate significantly enhanced insulin sensitivity. These initial results offer a potential new nutritional therapy for approximately 2 million American women suffering from Polycystic Ovarian Syndrome (PCOS). PCOS is a little-understood hormonal condition that is a leading cause of infertility, and is associated with insulin resistance, gestational diabetes and type 2 diabetes. The study was presented at the 59th Annual Meeting of the American Society for Reproductive Medicine Conference (ASRM) in San Antonio, Texas and appears in a supplement to Fertility and Sterility, September 2003.

In an effort to build on limited PCOS treatment options, researchers at the State University of New York (SUNY), Stony Brook, analyzed the effects of nutritional supplementation with chromium in the form of Chromax(R) chromium picolinate on six women with PCOS. Results showed that glucose disposal rate (insulin sensitivity) was significantly increased by an average of 35% after two months of treatment, and baseline insulin levels decreased by 22%.

"Chromium picolinate, which has positive effects on insulin sensitivity in people with type 2 diabetes, looks like it has great potential as a safe, effective long-term therapy to fill a void in treating PCOS," said Michael L. Lydic, MD, assistant professor at SUNY Reproductive Endocrinology Division, who led the study. "If larger, controlled trials confirm chromium picolinate's efficacy, PCOS patients could potentially take the supplement every day to decrease their risk of diabetes and possibly improve other physical and symptomatic effects of PCOS. It also has potential to be used in combination with prescription insulin-sensitizing drugs."

Today there is no FDA-approved drug specifically to treat PCOS. Some doctors prescribe insulin-sensitizing agents, such as metformin, however, many women experience unwanted side effects such as nausea, diarrhea, and loss of appetite, making ongoing treatment for insulin resistance prohibitive. Dr. Lydic added, "Our goal is to explore potential long-term therapies to bring insulin resistance under control and decrease risk of diabetes. Ideally, we hope to compare chromium picolinate with metformin in a clinical setting."

"An emerging body of research continues to confirm the hypothesis that chromium insufficiency is an important nutritional factor in insulin resistance which is strongly associated with the type 2 diabetes epidemic," said Gail Montgomery, President and CEO. "It is rewarding to see that Chromax supplementation shows promise as an affordable, convenient therapeutic option for women suffering from PCOS."

Clinical Design

The study was a non-randomized, prospective study, which included six women of reproductive age (18 -42 years old) with PCOS and signs of insulin resistance. Hyperinsulinemic, euglycemic clamp tests, the most accurate measure of insulin sensitivity, were used on all subjects.

Researchers measured hormonal, physical and symptomatic effects of improved insulin function. They reported that one subject without menstrual cycles, who had the largest change in glucose disposal rate, had a spontaneous menstrual period after 2 months. No adverse side effects were reported among the study participants.

The study was funded by NIH grant (#M01RR10710), and product was supplied by Nutrition 21, Inc.

About Chromium

Chromium is an essential mineral that is needed for insulin activity in carbohydrate, fat and protein metabolism. Numerous clinical trials have shown that chromium as chromium picolinate reduces insulin resistance, improves blood sugar control and may help reduce the risk of cardiovascular disease and type 2 diabetes.

About Nutrition 21

Nutrition 21 is an industry leader in using pharmaceutical quality research to substantiate the health benefits of nutritional supplements. It holds 22 patents for chromium compounds and their uses, and 13 other nutrition patents. The Company's proprietary technologies focus on chromium picolinate and its relationship to insulin resistance, a condition implicated in type 2 diabetes, cardiovascular disease, obesity and depression. Nutrition 21 markets Chromax(R) chromium picolinate, the leading chromium ingredient used in supplements. The Company is developing its first branded product, Diachrome(TM), for people with type 2 diabetes intended to be marketed through healthcare channels. More information is available at www.nutrition21.com, www.chromax.com, www.diachrome.com.

Editors Note: The study cited above was conducted and presented independently. Nutrition 21 distributed this press release, with the review and approval of the researchers.