NUTRITION 21, LLC ANNOUNCES THE PRESENTATION OF RESULTS OF A NITROSIGINE™ CLINICAL STUDY AT THE RENOWNED EXPERIMENTAL BIOLOGY 2014 ANNUAL MEETING
PURCHASE, NEW YORK – April 30, 2014 – Nutrition 21, LLC (“Nutrition 21”) ”) is proud to announce the presentation of new clinical study results supporting Nitrosigine™ inositol-stabilized arginine silicate, titled, “A Clinical Evaluation to Determine the Safety, Pharmacokinetics and Pharmacodynamics of an Inositol-Stabilized Arginine Silicate Dietary Supplement in Healthy Adult Males.” The study will be presented today to scientists and other professionals at the acclaimed Experimental Biology 2014 annual meeting’s poster session and will be published in the Federation of American Societies for Experimental Biology Journal (FASEB).
The clinical study demonstrated significant increases in plasma arginine levels (P<0.01) and serum silicon levels (P<0.01) after a single dose of Nitrosigine™. In addition, a significant increase in nitric oxide levels (measured as salivary nitrites) was seen after 14 days of product consumption (P<0.05). The results of the clinical study support the use of Nitrosigine™ as a bioavailable source of arginine and silicon, validating the preclinical studies and confirming Nitrosigine™ as an effective ingredient in products for sports nutrition, men’s health and cardiovascular health.
NO was measured using salivary test strips in a 10 subject clinical study, using a color scale for “Depleted”, “Low”, and “Normal” levels.
NO levels were measured in each study subject before, and at a number of time points after, administration of ASI as a single dose and after 14 days of daily dosing.
Primary author, Douglas S. Kalman, PhD, RD, CCRC, FACN, Director BD, Nutrition & Applied Clinical Trials at Miami Research Associates stated, “Nitrosigine, a new FDA-approved arginine-based molecule, has early and preliminary research that is deserving of further development.”
James Komorowski, MS, CNS, Vice President, Scientific & Regulatory Affairs of Nutrition 21 commented, “We are immensely pleased with the new clinical results. The clinical study confirms our pre-clinical work, and supports Nitrosigine’s™ ability to optimize the benefits of rigorous workouts by significantly increasing nitric oxide levels. Fitness-focused customers who want to get the most out of their training regimen, will appreciate that Nitrosigine™ is quickly absorbed by the body, taking effect in 30 minutes and lasting up to three hours. Nitrosigine™ has also been shown to significantly raise arginine and silicon levels – both important nutrients for cardiovascular performance.”
Consumer benefits directly linked to the clinical study findings include:
• Nitrosigine™ significantly enhances nitric oxide levels
• Nitrosigine™ is a safe, bioavailable source of arginine and silicon
• Nitrosigine™ significantly increases plasma arginine levels in 30 minutes
• Nitrosigine™ significantly increases plasma arginine levels for up to 3 hours
• Nitrosigine™ significantly increases silicon levels for up to 1.5 hours
“Nutrition 21 is thrilled to have the human clinical study available as support for our NDI-accepted, Nitrosigine™. Based on clinical and pre-clinical results, Nitrosigine™ demonstrates superiority over arginine as shown by increases in blood flow markers and silicon absorption. Nitrosigine™ is currently available in the retail channel in products such as, SuperPump® 3.0 and Razor8® and is in development in other finished goods. We anticipate continued high market interest with robust customer sales,” said Jim Kahn, Executive Director of National Sales at Nutrition 21.
About Experimental Biology 2014
The Experimental Biology (EB) meeting is a multi-society, interdisciplinary, biomedical, scientific meeting featuring plenary and award lectures, symposia, oral and poster sessions, a placement center, and an exhibit of scientific equipment, supplies, and publications. The meeting is one of the largest to date with over 14,000 attending scientists and researchers in the fields of anatomy, physiology, biochemistry, pathology, nutrition, and pharmacology. The Experimental Biology (EB) 2014 meeting held at the San Diego Convention Center, April 26 – 30, 2014.
For more information about the Experimental Biology 2014 annual meeting, please visit: www.experimentalbiology.org
About the Federation of American Societies for Experimental Biology (FASEB) JournalThe FASEB Journal is one of the world’s most cited biology journals. It is a preferred venue for the latest research reports and reviews of epigenetics, iRNA mechanics, histone acetylation, nitric oxide signaling, eicosanoid biochemistry, angiogenesis, tumor suppressor genes, apoptosis, cytoskeletal function, and human stem cell research. The journal publishes peer-reviewed, multidisciplinary original research articles, as well as editorials, reviews, and news of the life sciences.For more information about the Federation of American Societies for Experimental Biology, please visit: www.FASEB.org
About Nutrition 21, LLC
Nutrition 21, a wholly owned subsidiary of JDS Therapeutics, is a leader in the nutritional supplement industry. The Company is a developer and marketer of efficacious, high-value, clinically substantiated ingredients for dietary supplements, medical foods and beverages, including CHROMAX® chromium picolinate and NITROSIGINE™ inositol-stabilized arginine silicate. In 2013 NITROSIGINE™ was accepted by the FDA as a New Dietary Ingredient (NDI).
With many years of biotechnology and pharmaceutical experience, the Company’s scientific platform has created unique, patentable products that are safe and clinically effective. Rigorous preclinical and clinical trials are a key part of its product development strategy to ensure product safety and consumer trust.
Nutrition 21 currently holds over 100 domestic and international issued and pending patents for products. Many support unique claims associated with, among others, glucose metabolism, weight management, brain health, cardiovascular health, and sports nutrition.
For more information, please visit: www.Nutrition21.com
Nutrition 21, LLC
VP, Strategy and Business Development
Nutrition 21, LLC
Executive Director, National Sales
Director BD – Nutrition & Applied Clinical Trials