CLINICAL STUDIES EVALUATING THE EFFECTIVENESS OF PHASE 2

The leading clinical study carried out to evaluate the effectiveness of Phase 2 was a study conducted in Italy in September 2001. This was a study on 60 volunteers who were given a capsule before their high starch meals consisting of either 500 mg of Phase 2 or a placebo. After 30 days the Phase 2 group had experienced an average weight loss of 2.93 kg (6.45 lbs), which was 3.9% of their body weight and 10.45% of their body fat. The placebo group had an average weight loss of 0.34 kg (0.75 lbs).

A similar study was carried out in the United States in December 2002. In this study volunteers who were given Phase 2 to take before their high starch meals lost an average of 3.8 lbs over 8 weeks, this being an over 200% greater loss than those on a placebo. They also lost an average of 1.5 inches from their waist measurements, this being a 43% greater loss than those on a placebo.

Another such study was conducted in Norway and published in September 2000. This study used 40 obese volunteers and over 12 weeks the Phase 2 group achieved an average weight reduction of 3.5 kg (7.7 lbs), this comparing to a loss of 1.2 kg (2.6 lbs) for the study's placebo group. In addition body composition measurements showed that more than 85% of the weight loss achieved by the Phase 2 users was fat loss.

A different kind of study measures the amount of starch being absorbed by volunteers taking Phase 2, rather than the eventual weight they may lose. Such a study was carried out in the United States in September 2001 with volunteers taking 1500 mg of Phase 2 before eating starch and then having their blood glucose level monitored. The result was that the glucose level of the volunteers over a period of 150 minutes after eating was on average 57% less than that of the placebo group.

This study was repeated in November 2001, with volunteers again taking 1500 mg of Phase 2 before eating starch. This time their glucose level was on average 85% lower than the placebo group, meaning that only 15% of the glucose available from the food they had eaten had found its way into the body. The glucose also peaked 15 minutes earlier and cleared from the blood about 30 minutes earlier than occurred with the placebo group.

A further study of this kind was conducted with volunteers being given Phase 2 when eating a typical full meal, rather than a high starch food alone. The meal consisted of sirloin beef, mashed potatoes, mushrooms, beans, gravy and cherry-apple crumb cake. The amount of Phase 2 given to the volunteers in this study was 750 mg and this was mixed into the mashed potatoes. The result obtained from taking blood glucose levels was that starch absorption to the body had been reduced by an average of 28% when compared to the placebo group.

In addition to the above studies using human subjects, a study using rats has been conducted, published in March 2001. This study tested the digestive system of the rats for activity of alpha amylase, the enzyme that breaks down starches, and concluded that administering Phase 2 to the rats decreased amylase activity by 50 - 75%.