SAN CLEMENTE, Calif., Feb 20, 2006 (BUSINESS WIRE) -- Metagenics Inc., a privately held company focused on developing and manufacturing science-based nutraceuticals, announced today that the February issue of the peer-reviewed journal Nutrition (Vol. 22(2), pp. 104-113) features the results of a 2-arm prospective clinical trial in postmenopausal women at risk for cardiovascular disease (CVD). This clinical trial shows a greater improvement in established cardiovascular health markers when comparing a therapeutic lifestyle change (TLC) approach -- Metagenics' FirstLine Therapy(R) therapeutic lifestyle program (FLT) -- to a standard American Heart Association dietary plan (AHAD) and exercise.
CVD is the leading cause of death in women, with postmenopausal women at greatest risk. While elevated cholesterol and triglycerides are well-known risk factors for CVD, research suggests that insulin resistance and related conditions, such as metabolic syndrome and type 2 diabetes, are also key factors in CVD in postmenopausal women. Many dietary programs similar to the AHAD are low-fat, high-carbohydrate diets designed to lower elevated cholesterol levels. However, many individuals on these diets eat high-glycemic foods that can cause spikes in blood sugar -- increasing hunger, decreasing satiety (feeling of fullness), and fostering insulin resistance and a variety of related health problems. Most importantly, these diets often fail to produce the desired results in postmenopausal women. In contrast, the test program in this study (FLT program) incorporated a low-glycemic-index diet to help balance blood sugar, along with the same exercise program as the AHAD arm of the trial. The FLT protocol in this study also featured the nutritional support of a specially formulated powdered beverage containing a blend of soy protein and plant sterols -- acknowledged as natural agents that reduce the risk of CVD by the U.S. Food and Drug Administration, which has established food claims for both.
This 12-week study (53 subjects completing the trial) showed that the FLT program was significantly more effective than the AHAD protocol in not only improving levels of "good" HDL-cholesterol (HDL-C) and lowering triglycerides and "bad" LDL-cholesterol (LDL-C), but also in promoting weight loss, lowering blood pressure, and improving markers of CVD and insulin resistance.
"The (FirstLine Therapy) low-glycemic-index dietary plan and accompanying soy- and phytosterol-containing beverage, combined with a moderate exercise regimen, improved CVD disease risk factors to a significantly greater extent than conventional lifestyle and diet recommendations," said Robert H. Lerman, M.D., Ph.D., medical director of the Functional Medicine Research Center, the clinical research arm of Metagenics Inc. where the study was conducted. "Based on the positive effects on established clinical markers, (FLT) may be a viable protocol in postmenopausal women with concerns of cardiovascular disease, elevated cholesterol, and metabolic syndrome."
Highlights of Approximate Study Results
-- Total Cholesterol & LDL-C -- FLT program showed significantly greater improvements in all lipid parameters, including a 43 mg/dL decrease in total cholesterol (16%) and a 27 mg/dL decrease in LDL-C (15%), whereas no significant change was seen with the AHAD program.
-- HDL-Cholesterol -- increased significantly by 3 mg/dL (6%) on FLT, again with no significant change on the AHAD low-fat diet.
-- Triglycerides -- a 95 mg/dL decrease (45%) with FLT was about double that found on the other program.
-- Insulin Resistance -- FLT significantly improved markers of metabolic syndrome and insulin dysregulation, including fasting insulin, hemoglobin A1c, and the triglyceride-to-HDL-C ratio.
-- Blood Pressure -- FLT resulted in a more significant decrease in both systolic and diastolic blood pressure.
-- CVD Risk -- markers decreased more substantially with FLT, including homocysteine, high sensitivity C-reactive protein, and scores for Framingham coronary heart disease risk assessment.
"Emerging research led to the development of specialized nutritional support and therapeutic lifestyle changes for a non-pharmacologic approach to optimal health," said Jeffrey S. Bland, Ph.D., president and chief science officer of Metagenics Inc. "The results of this study should open the door for more focus on specific nutrients in the development of successful insulin and lipid management programs, and not just the number of calories as fat, protein, or carbohydrate in the program."
About the FirstLine Therapy Program
FirstLine Therapy (FLT) is an easy-to-use, practical system for healthcare practitioners to implement therapeutic lifestyle change programs in busy practices. FLT is effective because it addresses the underlying causes of common chronic disorders, not just the symptoms. The core focus of FLT -- which includes a low-glycemic-index dietary plan, nutritional supplements, exercise, and stress reduction techniques -- is helping patients to maintain or enhance lean body mass while they lose unhealthy fat. FLT integrates body composition testing (measuring body fat and lean mass) as well as indicators of cellular health as a part of patient assessment -- whereas many programs only measure weight or body mass index (BMI). These other programs often incorporate diets that may result in an excessive loss of muscle mass that is associated with accelerated aging and declining health. FLT also provides guidelines for science-based supplementation as therapeutic options for individual patients for an easily customized approach to condition management and disease risk reduction.
About Metagenics Inc.
Metagenics Inc. is a leading developer and manufacturer of science-based nutraceuticals sold to healthcare practitioners worldwide. The company has headquarters in San Clemente, with manufacturing and multiple research facilities located in Gig Harbor, Wash. -- including its MetaProteomics(R) Nutrigenomics Research Center and its Functional Medicine Research Center(SM) for human clinical research. Metagenics holds multiple proprietary formula patents and produces over 400 research-based products to optimize health. The company demonstrates its commitment to purity and quality through its certifications for Good Manufacturing Practices (GMP) from the NNFA, NSF International, and TGA. For more information about Metagenics, please visit the company's Web site at www.metagenics.com.