Dose-Response Pilot Study of Phase 2 Efficacy as an Inhibitor of Glucose Absorption with a Full Meal

Joe A. Vinson, PhD
January 26, 2004
University of Scranton

Objectives: Our previous studies with bread and margarine show 1.5 g of Phase 2 was efficacious in decreasing the absorption of starch calories as measured by plasma glucose. This study is to determine if a low dose of Phase 2 is successful in decreasing the absorption of glucose from a full meal.

Methodology: Seven subjects (3 males and 4 females) participated in the study with informed consent. They appeared at Toxi-Con Labs after an overnight fast and a fasting blood sample taken. They then consumed in 10 minutes a micro-waved control meal (Hungry-Man Frozen Country Fried Beef Steak containing 630 calories with 64 g of carbohydrates, 29 g of protein and 29 g of fat in the form of breaded sirloin beef patties, mashed potatoes with gravy, mushrooms, green beans, and cherry- apple crumb cake ) with 240 ml of water or the same meal with 0.75 g of Phase 2 added to the potatoes. They were given the two different meals in a random blinded fashion and sampled periodically over a period of 2 hours. Plasma glucose was automatically analyzed by a certified clinical laboratory and the results evaluated.

Results: Enclosed is the figure for 7 subjects taking the full meal and 0.75g of Phase 2. The glucose level is lower at 10 min, 40 min and 50 min with Phase 2 compared with the control as seen in the graph. Also plasma glucose reaches the baseline 12 min earlier with Phase 2, i.e. glucose is cleared more quickly from the plasma with Phase 2. The area under the change in plasma glucose-time curve is 28% lower after Phase 2 compared with the control.
This low dose appears to be effective and a significant difference may arise with more subjects added to the protocol or with a higher dose of Phase 2.

Summary of Clinical Study Evaluating Effectiveness of Phaseolamin™

Conducted by Dr. R. Ballerini,
Managing Director of Pharmeceutical Development and Service srl. (Milano, Italy)

Evaluation of efficacy and safety of a food supplement for weight control through the reduced calories-intake from carbohydrates vs. placebo (double blind test)

SUMMARY

A study on 60 human healthy volunteers, males and females, aged 20-45 years, which had been characterized by a 5 - 15 kg. overweight for at least 6 months was conducted to evaluate safety and efficacy of a food supplement intended to help weight loss by reducing absorption of calories from carbohydrates, comparing such a product vs. a placebo.
The study was performed upon request from Consorzio RTC – Ricorche e Tecnologie Cosmetologiche.

The considered products were identified as Blockal batch D106B and Blockal batch 1600301.
An envelope containing qualitative and quantitative formulations of the samples and the key for the identification of the products was given to the Study Responsible and, if necessary was available for the researchers during all the study. At the end of the study the envelope was opened, and products and formulations identified in front of the Study Responsible and of a RTC delegate.

To highlight the activity claimed by the considered product, volunteers were asked to take a tablet before a meal rich of complex carbohydrates.

In this sense, 30 days before starting the test (t-30) each subject was controlled by a Dietician, that gave him/her a table with nutritional suggestions, recommending the daily assumption of complex carbohydrates during one of principal meals, so that they could get used to this regimen.

All volunteers undertook to take the Dietician’s advice and their weight was registered after 10, 20 and 30 days. Only 60 volunteers whose weight remained stable in such a period were recruited for the study.

A 30-day double blind test for home use of the food supplement, with LAB control, was then performed.

Volunteers were divided in two homogenous groups (sex, age, weight) and took 1 tablet a day of the considered products, in the correspondence of the meal with complex carbohydrate high content, for 30 days as follows:
Group 1: Blockal batch D106B
Group 2: Blockal batch 1600301

RESULTS

Group 1 (Blockal batch D106B)
At the end of the study (t30) results highlighted that the product determined a weight loss of kg 2,933 (corresponding to 3.90% of total body weight). Such a weight loss also determined a 10.45% reduction of fat body mass, without significant modifications of lean body mass.

Results also highlighted that the product determined a 11.63% reduction of adipose membrane (by echography), a 3.44% reduction of waistline, a 1.39% reduction of hips circumference and a 1.44% reduction of thigh circumference.

Personal evaluation also highlighted a good tolerability and a good efficacy of the considered product.

Group 2 (Blockal batch 1600031)
At the end of the study (t30) results highlighted that the product determined a weight loss of kg 0.348 (corresponding to 0.47% of total body weight) without significant modifications of fat body mass and of lean body mass.

Results also highlighted that the product determined a 1.30% reduction of adipose membrane (by echography), a 0.53% reduction of waistline, a 0.10% reduction of hips circumference and a 0.39% reduction of thigh circumference.

Personal evaluation also highlighted a good tolerability and a low efficacy of the considered product.

At the end of the study, the Study Responsible compared the formulations of considered product that resulted as follows:

Blockal batch D106B (Group 1): food supplements containing active ingredients inhibiting carbohydrate absorption (includes 500mg of Phaseolamin 2250™)

Blockal batch 1600031 (Group 2): placebo

CONCLUSIONS

Results suggest that Blockal batch 1600031 (placebo) did not determine significant modifications of the considered parameters, while Blockal batch D106B demonstrated a good efficacy in reduction of calories intake form complex carbohydrates for an easier, correct and balanced weight loss (calculated by impedance measure), with reduction of adipose membrane thickness (echography) and a reduction of waistline, hips circumference and thigh circumference.

Such results have to be correlated with the specific composition of the product, that contains a vegetal glycoprotein capable of inhibiting pancreatic a-amylase. Such a protein (weight 49,000 Daltons) demonstrated in vitro an inhibition corresponding to 3,000 units per gram).

It should also be stressed that in this study, food supplement was administered in correspondence of a complex carbohydrate high content meal, and that complex carbohydrates can be absorbed only after enzymatic parting trough pancreatic amylases.

Weight loss, particularly of fat body mass, can be reconducted to a lower absorption of complex carbohydrates, due to the activity of the vegetal glycorprotein included in the food supplement taken before the meal.

The study demonstrated the real capability of the considered product to determine in vivo weight loss trough fat body mass reduction via a reduced absorption of complex carbohydrates, that represent a relevant, or even excessive, part of calories intake.