Phaseolamin
Encyclopedia
Phaseolamin is a generic name for a proteinaceous inhibitor
Enzyme inhibitor
An enzyme inhibitor is a molecule that binds to enzymes and decreases their activity. Since blocking an enzyme's activity can kill a pathogen or correct a metabolic imbalance, many drugs are enzyme inhibitors. They are also used as herbicides and pesticides...

 of the enzyme
Enzyme
Enzymes are proteins that catalyze chemical reactions. In enzymatic reactions, the molecules at the beginning of the process, called substrates, are converted into different molecules, called products. Almost all chemical reactions in a biological cell need enzymes in order to occur at rates...

 alpha-amylase
Alpha-Amylase
α-Amylase is an enzyme that hydrolyses alpha-bonds of large alpha-linked polysaccharides such as starch and glycogen, yielding glucose and maltose. It is the major form of amylase found in humans and other mammals...

 that is made from white beans. A number of amylase
Amylase
Amylase is an enzyme that catalyses the breakdown of starch into sugars. Amylase is present in human saliva, where it begins the chemical process of digestion. Food that contains much starch but little sugar, such as rice and potato, taste slightly sweet as they are chewed because amylase turns...

 inhibitors from white beans have been marketed over the years as weight control remedies.

Background

As reported in JAMA
Journal of the American Medical Association
The Journal of the American Medical Association is a weekly, peer-reviewed, medical journal, published by the American Medical Association. Beginning in July 2011, the editor in chief will be Howard C. Bauchner, vice chairman of pediatrics at Boston University’s School of Medicine, replacing ...

, early phaseolamin products did not have sufficient potency or stability to effect any in vivo
In vivo
In vivo is experimentation using a whole, living organism as opposed to a partial or dead organism, or an in vitro controlled environment. Animal testing and clinical trials are two forms of in vivo research...

 changes. In addition, impurities contained therein caused complaints of GI distress including flatulence. In the late 1990s, the first standardized starch
Starch
Starch or amylum is a carbohydrate consisting of a large number of glucose units joined together by glycosidic bonds. This polysaccharide is produced by all green plants as an energy store...

 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 carbohydrate
Carbohydrate
A carbohydrate is an organic compound with the empirical formula ; that is, consists only of carbon, hydrogen, and oxygen, with a hydrogen:oxygen atom ratio of 2:1 . However, there are exceptions to this. One common example would be deoxyribose, a component of DNA, which has the empirical...

s, allowing a portion of them to pass through the system before they can be converted into glucose
Glucose
Glucose is a simple sugar and an important carbohydrate in biology. Cells use it as the primary source of energy and a metabolic intermediate...

, 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 Europe.

Clinical trial results

A double-blind
Double-blind
A blind or blinded experiment is a scientific experiment where some of the people involved are prevented from knowing certain information that might lead to conscious or subconscious bias on their part, invalidating the results....

, placebo-controlled study of 60 human subjects showed that those who took Phase 2 lost an average of 6.45 lb (2.9 kg) in 30 days, compared to those on placebo
Placebo
A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient...

, who lost less than 1 lb (0.45359237 kg), on average. Those participants on Phase 2 also lost, on average, over 10% of body fat 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 in Rome
Rome
Rome is the capital of Italy and the country's largest and most populated city and comune, with over 2.7 million residents in . The city is located in the central-western portion of the Italian Peninsula, on the Tiber River within the Lazio region of Italy.Rome's history spans two and a half...

. Analysis was conducted by Harry Preuss MD, Georgetown University Medical Center
Georgetown University Medical Center
Georgetown University Medical Center is the medical campus at Georgetown University. It is also a $225 million biomedical research and educational organization. The Medical Center contains over 80% of Georgetown University's sponsored research funding and is led by Howard J...

; and Nicholas Perricone
Nicholas Perricone
Dr. Nicholas Perricone , MD, is a dermatologist who has written several books, primarily on the subjects of weight loss and maintaining the appearance of youth. Dr. Perricone is an Adjunct Professor of Medicine at Michigan State University’s College of Human Medicine, from which he received his MD....

 MD, of Clinical Creations, Meriden, Connecticut
Meriden, Connecticut
Meriden is a city in New Haven County, Connecticut, United States. According to 2005 Census Bureau estimates, the population of the city is 59,653.-History:...

. The study was published in the International Journal of Medical Sciences
International Journal of Medical Sciences
International Journal of Medical Sciences is an Open Access medical journal published by Ivyspring International Publisher. The scope of the journal covers various areas of basic medical sciences, clinical and experimental research related to the studies of human diseases. Articles include...

, 2007.

A double-blind, placebo-controlled, crossover
Crossover study
A crossover study is a longitudinal study in which subjects receive a sequence of different treatments . While crossover studies can be observational studies, many important crossover studies are controlled experiments, which are discussed in this article...

 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
University of Scranton
The University of Scranton is a private, co-educational Catholic and Jesuit university, located in Scranton, Pennsylvania, in the northeast region of the state. The school was founded in 1888 by Most Rev. William O'Hara, the first Bishop of Scranton, as St. Thomas College. It was elevated to a...

, 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
Stratified sampling
In statistics, stratified sampling is a method of sampling from a population.In statistical surveys, when subpopulations within an overall population vary, it is advantageous to sample each subpopulation independently. Stratification is the process of dividing members of the population into...

 by total carbohydrate intake, the Phase 2 group lost an average of 8.7 lb (3.9 kg) and 3.3 inches off their waists, while the placebo group lost an average of 1.7 lb (0.771107029 kg) 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 (1.7 kg) pounds, compared with an average of 1.65 lb (0.7484274105 kg) 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(glycemic index)testing showed that the GI of Wonder brand white bread
Wonder Bread
Wonder Bread is the name of three North American brands of white bread: One produced by George Weston Bakeries in Canada, another by Hostess Brands in the United States, and the third by Grupo Bimbo in Mexico.- United States :...

 was significantly reduced by the addition of 3000 mg 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)

Doubts have been expressed about the efficacy of phaseolamin by Ray and Terry's products, a supplement company connected with Ray Kurzweil. On its website, the company claims to have carried out trials which did not indicate that it worked well.
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