Study To Measure Effects of Nutritional Supplementation on Diabetes & Heart Disease Risk Factors
Purchase, NY, February 12, 2004, Nutrition 21 (NASDAQ: NXXI) – The University of Pennsylvania Department of Medicine today announced the initiation of a double-blind, randomized, placebo-controlled human clinical trial to study the potential benefits of chromium picolinate supplementation in men and women diagnosed with Metabolic Syndrome. The study is funded by a grant from the National Institutes of Health (NIH). The NIH National Cholesterol Education Program (NCEP) has identified Metabolic Syndrome as an important target of therapy, linked to increased risk of heart disease and type 2 diabetes, and affecting approximately 22% of Americans.
The new 20-week study will assess the effects of nutritional supplementation with 1,000 mcg of chromium per day, as chromium picolinate, compared to matching placebo, on insulin resistance and other cardiovascular clinical factors in adults with Metabolic Syndrome. The NCEP defines Metabolic Syndrome as a cluster of symptoms that include abdominal obesity, impaired glucose tolerance, dyslipidemia and raised blood pressure.
“The results from this clinical trial will provide solid data on chromium picolinate’s potential to impact key clinical factors in this high-risk, pre-diabetic population,” according to Phillippe O. Szapary, MD, Assistant Professor of Medicine, University of Pennsylvania, and principal investigator of the study. “Supplemental chromium may serve as an attractive therapeutic option for patients diagnosed with Metabolic Syndrome.”
While there are several forms of chromium available, chromium picolinate was selected for this study, because it is the most commonly used and chemically stable form of the mineral, according to Dr. Szapary. Chromax® chromium picolinate will be provided by Nutrition 21 for the study.
Sixty subjects will include adult men and women who have been diagnosed with Metabolic Syndrome based on the NCEP guidelines.
The trial will evaluate the benefit of chromium picolinate to help improve insulin sensitivity, as measured by several indices obtained from an intravenous frequently sampled glucose tolerance test. This study will also quantify the effects of chromium picolinate supplementation on other important clinical factors including: serum HDL cholesterol, fasting triglycerides (TG), weight/body composition, and blood pressure.
In addition, the study will investigate the relationship between chromium status and effects on insulin sensitivity as well as the prevalence of chromium deficiency in people with Metabolic Syndrome.
Other exploratory aims of the research include investigation of chromium picolinate’s potential as an antioxidant and anti-inflammatory agent. “This study will provide the first human data on the effects of chromium picolinate supplementation on state-of-the-art readouts of oxidant stress and inflammation, which are important intermediates in the development of both type 2 diabetes and heart disease,” according to Dr. Szapary.
The study is funded by the Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH grant #1R21DK067241-01), and the National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK).
Chromium is an essential mineral that is needed for insulin activity in carbohydrate, fat and protein metabolism. A number of studies have shown that chromium in the form of chromium picolinate helps reduce insulin resistance, improve blood sugar control, and may help reduce risk of cardiovascular disease and type 2 diabetes.
About Nutrition 21
Nutrition 21 is the leading maker of chromium-based nutritional supplements, whose health benefits are substantiated by clinical research. The company markets Chromax chromium picolinate, the leading brand of nutritional chromium, and holds 35 patents for nutrition products, 22 for chromium compounds and their uses. More information is available at www.nutrition21.com and www.chromax.com.
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