is a generic name for a proteinaceous inhibitor of the enzyme alpha-amylase that is made from white beans. Based on the early research on Phaseolamin, a number of amylase inhibitors from white beans have been marketed over the years as weight control remedies. But as reported in JAMA, early phaseolamin products did not have sufficient potency or stability to affect any in vivo changes. In addition, impurities contained therein caused complaints of GI distress including flatulence. In the late 1990s, the first standardized starch blocker, Phase 2® Carb Controller (also known as StarchLite), was developed . Phase 2 is a fractionated extract of the white bean that has been clinically shown in 13 studies to delay the digestion and absorption of starch calories. Phase 2 neutralizes some of the digestive enzyme alpha amylase, temporarily delaying the digestion and absorption of carbohydrates, allowing a portion of them to pass through the system before they can be converted into glucose, and then fat. Phase 2 is considered generally recognized as safe by independent toxicologists and usually does not cause side effects. Phase 2 is available as an ingredient that can be formulated in a variety of nutritional supplements, foods and beverages. It is also sold as StarchLite™ in the food marketplace and in Europe.
Clinical trial results
A double-blind, placebo-controlled study of 60 human subjects showed that those who took Phase 2 lost an average of 6.45 lbs in 30 days, compared to those on placebo, who lost less than 1 lb, on average. Those participants on Phase 2 also lost, on average, over 10% of body fast mass, and more than 3% in waist circumference. The study was conducted by Leonardo Celleno MD, Alessandra D’Amore MD, and Maria Toliani of the Cosmetic Research Center, Rome, Italy. Analysis was conducted by Harry Preuss MD, Georgetown University Medical Center; and Nicholas Perrricone MD, Clinical Creations Meriden CT. The study was published in the International Journal of Medical Sciences 2007.
A double-blind, placebo-controlled, cross-over pilot study of 11 adult human subjects showed that starch absorption averaged 66% less in the group taking Phase 2. The study was conducted by Joe A. Vinson, Ph.D., and Donna M. Shuta, B.S., Department of Chemistry, University of Scranton, April 24, 2002.
A double-blind, human pilot study published in Alternative Therapies in Health and Medicine found that those who ate the most carbohydrates and took a supplement containing Phase 2, lost significantly more weight and inches from their waist than the placebo group. When stratified by total carbohydrate intake, the Phase 2 group lost an average of 8.7 lbs and 3.3 inches off their waists, while the placebo group lost an average of 1.7 lbs and 1.3 inches. The results were statistically significant.
In a clinical trial performed by Jay Udani, MD (Assistant Clinical Professor at the UCLA School of Medicine), a randomly selected group of obese subjects were given 1500 mg of Phase 2 twice daily with meals. Over the period of the eight week trial, which 27 subjects completed, the group using Phase 2 showed an average weight loss of 3.79 pounds, compared with an average of 1.65 pounds for subjects taking a placebo. No adverse effects were observed during the trial. The study was published in Alternative Medicine Review, Volume 9, Number 2, March 2004.
An open-label 6-arm crossover study with 13 randomized subjects using standardized GI testing showed that the GI of Wonder Brand White Bread was significantly reduced by the addition of 3000mg of the Phase 2/StarchLite white bean extract in powder form with other dosages and formulations trending toward significance. The study was conducted by Jay Udani, MD Medical Director, Medicus Research)
- Celleno L, Tolaini M, D'Amore A, Perricone N, Preuss H (2007). "A Dietary Supplement Containing Standardized Phaseolus vulgaris Extract Influences Body Composition of Overweight Men and Women". International Journal of Medical Sciences 4 45-52..
- Joe A. Vinson, Ph.D., and Donna M. Shuta, B.S. "Investigation of an Amylase Inhibitor on Human Glucose Absorption After Starch Consumption".
- Jay Udani, MD, Medical Director, Integrative Medicine Program, Northridge Hospital Medical Center, Northridge, CA; Betsy Singh, Ph.D., Dean of Research, Southern California University of Health Sciences (2007). "Blocking Carbohydrate Absorption and Weight Loss: A Clinical Trial Using a Proprietary Fractionated White Bean Extract". Alternative Therapies in Health and Medicine 13 (4):
- Jay Udani, MD, Mary Hardy, MD, and Damian C. Madsen "Blocking Carbohydrate Absorption and Weight Loss: A Clinical Trial Using Phase 2® Brand Proprietary Fractionated Bean Extract". Alternative Medicine Review 9
- Jay Udani, MD Medical Director, Medicus Research "A Novel Method of Lowering the Glycemic Index of White Bread Using a Proprietary White Bean Extract".