Human Clinical Data Presented at 25th American College of Toxicology Conference
PURCHASE, NY, November 9, 2004 – Nutrition 21, Inc. (Nasdaq: NXXI) – Three new studies re-affirm the safety of the nutritional ingredient Chromax® chromium picolinate, further validating a rapidly increasing body of peer-reviewed scientific research. One of the three studies, presented today at the 25th Annual Meeting of the American College of Toxicology (ACT) in Palm Springs, CA, is a double-blind, placebo controlled trial of 110 patients. No significant adverse effects where found in the 70 clinically depressed patients receiving 400-600 mcg of chromium as chromium picolinate orally for up to eight weeks. The abstract will be published in the December issue of the International Journal of Toxicology.
“These data add to the large body of evidence, including more than 60 studies, confirming that Chromax chromium picolinate is safe,” according to James Komorowski, MS, Vice President of Technical Services and Scientific Affairs for Nutrition 21. “Results from double-blind, placebo controlled studies using commonly consumed doses of chromium picolinate ensure the relevance and credibility of the findings.”
Separately, new research from Purdue University, published in the International Journal of Sports Nutrition and Exercise Metabolism1, confirmed chromium picolinate’s safety in non-diabetic individuals who performed resistance training twice weekly and received 924 mcg of chromium as chromium picolinate for twelve weeks. For those taking chromium picolinate, clinical indices of kidney and liver functions were within the normal ranges at baseline and at the end of the study. “These results, confirming earlier findings, demonstrate that high doses of chromium picolinate are safe and do not cause damage to kidney and liver tissues.”
New government funded research results have also been released by the National Institutes of Health (NIH) National Toxicology Program (NTP) evaluating chromium picolinate’s safety. The NTP report has been accepted for publication in the journal of Food and Chemical Toxicology2 The NTP found no negative effects from chromium picolinate in its rigorous 13-week toxicity studies on rats and mice, which further confirms previous pre-clinical findings. In addition, the NTP and the National Cancer Institute (NCI) tested chromium picolinate using the Ames assay, and a genotoxicity test for mutagenesis and found no toxicity. These tests were performed under the U.S. Environmental Protection Agency’s standards for evaluating toxicity of minerals, which validates prior in vitro findings.
Chromax® chromium picolinate has been affirmed as Generally Recognized as Safe (GRAS) by an independent expert panel of prominent scientists with toxicology and medical experience. "The safety research overwhelmingly confirms that Chromax chromium picolinate is a safe nutritional supplement,” according to Ronald S. Slesinski, PhD, DABT, president-elect of the Regulatory & Safety Specialty Section of the Society of Toxicology. “It has never been shown to be mutagenic in animals or to produce damage to genetic material (DNA) in humans when ingested at any dose." Chromax is the most studied form of nutritional chromium and is approved for use in foods.
The Role of Chromium in Health
Chromium is an essential mineral that is critical to proper insulin function and for maintaining healthy blood sugar levels. Clinical studies have shown nutritional supplementation with chromium, in the form of chromium picolinate, can improve insulin function and blood sugar control in people with insulin resistance and type 2 diabetes.
“Researchers, health professionals and consumers can be confident in the safety and efficacy of Chromax, and its critical role in improving metabolic health,” said Gail Montgomery, President & CEO, Nutrition 21.
1 Campbell WW, Joseph LJ, Ostlund RE Jr, Anderson RA, Farrell PA, Evans WJ.
Resistive training and chromium picolinate: effects on inositols and liver and kidney functions in older adults. Int J Sport Nutr Exerc Metab. 2004 Aug;14(4):430-42.
2 M.C. Rhodes, C.D. Hébert, R.A. Herbert, E.J. Morinello, J.H. Roycroft, G.S. Travlos and K.M. Abdo. Absence of toxic effects in F344/N rats and B6C3F1 mice following subchronic administration of chromium picolinate monohydrate • Food and Chemical Toxicology, In Press, (www.elsevier.com).
About Nutrition 21, Inc.
Nutrition 21 is a biosciences company dedicated to the research, development and commercialization of innovative chromium-based nutrition products for improved health maintenance, and for the prevention and treatment of metabolic diseases such as diabetes, insulin resistance, obesity, depression and cardiovascular disease. Nutrition 21 holds 34 patents for nutrition products, 25 of which are for chromium compounds and their uses. Nutrition 21’s Chromax® chromium picolinate is a form of the essential mineral chromium developed by the USDA and licensed to the Company. It is used as an ingredient in many nutritional supplements. More information is available at www.nutrition21.com.
# # #
Stacey Antine, MS, RD,