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Starch Neutralizer

Phase 2 starch neutralizer 60 years of research

Specific inhibitors of animal alpha amylases (the enzyme that helps turn starch to sugar) were discovered in plants, particularly wheat and beans, as early as the 1940s. Interest in such inhibitors developed because controlled reduction of starch digestion theoretically could improve carbohydrate tolerance in pre-insulin diabetics and aid in weight control.

However, it was not until the early ’70s that the first research was conducted on wheat and beans to determine the specific starch neutralizing ability of the plants. In 1973 an amylase inhibitor from wheat was reported to decrease postprandial (after a meal) plasma glucose rise in response to raw wheat starch.

In 1974 J. John Marshall and Carmen M. Lauda purified a proteinaceous inhibitor of alpha amylase from kidney beans (Phaseolus Vulgaris), which they named Phaseolamin.

Marshall and Lauda performed the first in vitro (laboratory) research on Phaseolamin and concluded it was a specific alpha amylase inhibitor. Based on that early research, a number of crude bean amylase inhibitor preparations were commercially marketed in 1980 as weight control remedies.

FDA Suspends Sales of Starch Blockers
The early remedies were marketed as “starch blockers,” and claimed to reduce starch digestion by inhibiting intraluminal amylase activity. Numerous clinical studies, however, failed to show that the amylase inhibitors reduced starch digestion in humans. Consequently, the FDA suspended sales of the products in 1982.

According to an article by Mayo Clinic Researchers in 1985, the “clinical studies of these commercial amylase inhibitors, given with a starch meal, failed to influence fecal calorie excretion; postprandial concentrations of plasma glucose or breath hydrogen, and metabolism of C-labeled starch.”

Following the FDA ruling, the Mayo Clinic launched a study to determine why the commercial preparations were ineffective in vivo (within the living organism) in spite of their anti-amylase activity in vitro. The results of their study, “Partially Purified White Bean Amylase Inhibitor Reduces Starch Digestion In Vitro and Inactivates Intraduodenal Amylase in Humans,” concluded that “commercial amylase inhibitors failed to decrease starch digestion in vivo mainly because they have insufficient anti-amylase activity.”

Partially Purified Inhibitor Contains
More Anti-Amylase Activity
The Mayo Clinic researchers also found that partially purified inhibitor, prepared by simple extraction of crude bean powder, has much more specific anti-amylase and less agglutinating activity compared with commercial preparations. They further concluded that “a partially purified inhibitor, with increased specific activity, is stable in human gastrointestinal secretions, slows dietary starch digestion in vitro, rapidly inactivates amylase in the human intestinal lumen, and at acceptable oral doses, may decrease intraluminal digestion of starch in humans.”

Based on this positive research, a number of companies began to reexamine use of amylase inhibitors for reducing starch digestion in diabetics and for weight control. Following enactment of DSHEA in 1994, new commercial weight reduction products containing amylase inhibitors were introduced—but with more modest claims.

Brad King, author of the internationally best-selling book Fat Wars, has this to say about the importance of reducing starch in the diet: “As a researcher in the field of obesity, I feel it is of extreme importance for the general public to understand the dangers associated with the excess consumption of high-glycemic carbohydrates. These unassuming low-fat foods such as processed snacks, breads, white rice and even baked potatoes, have become the staple of our North American diets. To ignore the facts surrounding the body’s inability to properly metabolize these quick digesting sugars in abundance, is to turn a blind eye to one of the root causes of the epidemic we are now faced with. A clinically proven extract of the white kidney bean (Phase 2), can safely reduce the absorption of excess starches, offering assistance for those who may find it next to impossible to abstain from these foods.”

New Product Contains Standardized Extract
Pharmachem Laboratories, a major U.S. supplier of nutritional supplement ingredients, recently introduced Phase 2™ (Phaseolamin 2250®), the first standardized, all-natural, non-stimulant starch neutralizer, extracted from a portion of the white kidney bean. Phase 2 is similar to the extract studied by the Mayo Clinic. In an independent in vitro test by Lycoming Laboratories, using a modified USP test method, Phase 2 neutralized 2,250 starch calories—or the equivalent of over one pound of spaghetti. Few, if any, side effects have been observed from Phase 2—even at high doses. It is manufactured in the U.S. from a non- GMO plant source. It is all natural and contains no stimulants. It is generally regarded as safe (GRAS).

Studies Confirm Efficacy, Safety
Pharmachem Laboratories recently completed the first human studies to demonstrate the effectiveness of a natural, standardized bean extract. In a double-blind, placebo-controlled, cross-over pilot study of 11 adult human subjects, starch absorption averaged 66 percent less in the group taking Phase 2. (Joe A. Vinson, Ph.D. and Donna M. Shuta, B.S., Department of Chemistry, University of Scranton, April 24, 2002.)

In a double-blind, placebo-controlled study of 60 human subjects, those on Phase 2 lost an average of 6.45 pounds in 30 days, compared to those on placebo, who lost less than one pound on average. Those participants on Phase 2 also lost, on average, over 10 percent of body fat mass, more than three percent in waist circumference and measurable percentages off their hips and thighs. There was no loss of lean body mass. (Dr. R. Ballerini, managing director of Pharmaceutical Developments and Service, Milano, Italy, Sept. 7, 2001.)

Phase 2 is safe and non-toxic, according to a recent LD 50 Acute Toxicity Study. The study demonstrated that Phase 2 showed absolutely no toxicity in rats at doses as high as 5.0 g/kg body weight. (Ramadasan Kuttan, Ph.D., director of Amala Cancer Research Center, Trichur, India, and R.C. Srimal, M.D., April 29, 2002.)

Based on the results of these recent studies, Phase 2 appears to be a safe, nonstimulant carbohydrate control mechanism that produces weight loss by reduction of fat mass while preserving lean body mass.

Dennis Meiss, Ph.D. serves as a consultant to Pharmachem Labs and is involved in the design and interpretation of clinical trial results for Phase 2.

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