PARSIPPANY, N.J., Feb. 2, 2011 /PRNewswire/ -- DSM Nutritional Products today announced a new study published in the international peer-reviewed journal, Maturitas, that offers new hope for women suffering from hot flashes and night sweats.(1) The data shows that geniVida®, a non-soy, non-hormonal genistein dietary ingredient and the active ingredient in DSM's i-cool™, is a safe and effective non-drug option for the management of hot flashes and night sweats in postmenopausal women.
"These findings are encouraging for the 42 million women aged 45 years and above in the United States who experience these menopausal symptoms(2)," said Dr. Malkanthi Evans, Scientific Director, KGK Synergize Inc. and lead study author.
These new data demonstrate that of the subjects who completed at least 4 weeks on trial (n=40), the women on geniVida experienced an average of 51% reduction in hot flashes and night sweats by week 12 compared to only 27% for the placebo group (p<0.026), a highly statistically significant difference. The corresponding reduction in total duration of hot flashes and night sweats per day was also statistically significant. Additionally, although not reported in the publication, the study showed 28% of the women in the geniVida group experienced an 85% reduction in their hot flashes (p<0.0002).
"This exciting new study reinforces the proven efficacy and safety of geniVida, the active ingredient in DSM's i-cool supplement," said James Elliott, Ph.D. director of nutritional science for DSM Nutritional Products. "i-cool has already helped tens of thousands of women manage their hot flashes and night sweats and we look forward to the relief this product can bring to the millions of other women who suffer from these symptoms."
About the Study
This randomized, double-blind, placebo-controlled study was conducted at five clinical centers in Ontario, Canada under the highest scientific standards. The study participants included 84 healthy postmenopausal women between the ages of 40 and 65, suffering from a minimum of 40 hot flashes or night sweats per week and in a physiological state of natural or surgical menopause. The participants were randomly assigned to consume placebo or a single 30 mg daily dose of geniVida for 12 weeks.
There was no significant difference between subjects on geniVida or placebo with respect to the number of subjects who experienced at least one adverse event.
geniVida is a 99% pure, synthetic, non-soy genistein dietary ingredient from DSM. It is available in both food- and pharmaceutical-grade and is supported by extensive, published safety studies. geniVida is available in both crystalline and tablet-grade forms.
About DSM Nutritional Products
DSM Nutritional Products is the world's leading supplier of vitamins, carotenoids and other fine chemicals to the feed, food, pharmaceutical and personal care industries. The business has sales of over $2.5 billion U.S. and a long tradition as a pioneer in the discovery of new products, new formulations and attractive applications for all industry segments. More information is available at email@example.com and www.qualityforlife.com.
DSM – the Life Sciences and Materials Sciences Company
Royal DSM N.V. creates innovative products and services in Life Sciences and Materials Sciences that contribute to the quality of life. DSM's products and services are used globally in a wide range of markets and applications, supporting a healthier, more sustainable and more enjoyable way of life. End markets include human and animal nutrition and health, personal care, pharmaceuticals, automotive, coatings and paint, electrical and electronics, life protection and housing. DSM has annual net sales of about $10 billion U.S. and employs some 22,700 people worldwide. The company is headquartered in the Netherlands, with locations on five continents. DSM is listed on Euronext Amsterdam. More information: www.dsm.com.
KGK conducts human clinical trials in support of health, nutrition, biotechnology and pharmaceutical industries. In addition to its contract research capabilities, KGK's Product Development Division brings new and innovative natural health products to the point where they are ready to manufacture and market. These products include Sytrinol®, Diabetinol™ and Dermytol™.
For media inquiries please contact:
William J. Brown
DSM Nutritional Products
Tel: 973 257 8288
(1) Evans M, et al. The effect of synthetic genistein on menopause symptom management in healthy postmenopausal women: A multi-center, randomized, placebo-controlled study. Maturitas 2011;68:189-96.
(2) Datamonitor (04/2008): Commercial and Pipeline Insight: HRT for Menopausal Symptoms.
SOURCE DSM Nutritional Products