November 20 - In vivo effectiveness of a starch absorption
blocker in a double-blind placebo-controlled study with
normal college-age subjects.
Joe A. Vinson, PhD and
Donna M. Shuta, BS
Department of Chemistry
University of Scranton
Scranton, PA 18510
Inhibition of carbohydrate
metabolism or absorption is one mechanism to reduce hyperglycemia
in normal and especially
in diabetic subjects. Another possible benefit is the
decrease in calorie intake after eating carbohydrates
for obesity and weight loss. In the 1980's there were
several reports of in vitro and in vivo effectiveness
of a natural starch blocker that worked by inactivating
the enzyme amylase. We investigated this hypothesis with
an initial pilot study. After this initial study with
subjects who were physically active during the study,
we did a second study to confirm the results. In this
second study, again there was a double-blind placebo-controlled
crossover trial with ten subjects (five males and five
females aged 21 to 27) who participated with informed
consent. After an overnight fast the subjects appeared
in the morning and were given in a random fashion either
1) placebo consisting of 4 slices of white bread (60
g
of carbohydrate), 42 g of soybean oil margarine, and
4 g of Sweet N'Low; 2) experimental comprising the control
plus 1.5 g of Phase 2® (Pharmachem Laboratories).
The subjects rested between blood drawings. Plasma glucose
was measured from blood sample drawn at baseline and
every
15 minutes for 1 hour, then every 20 minutes for the
second hour. Two subjects did not complete the study
and 4 subjects
were poor/non-absorbers as the area under the glucose-time
curve was negative. Therefore the data of the remaining
4 subjects was used.
As expected the control bread produced an increase in
glucose in the normal subjects that reached a broad peak
after 45 minutes. The peak glucose for the Phase 2® group occurred at 30 minutes. This dose of Phase 2® produced a smaller increase than the control from
15 to 80 minutes, with an almost significant difference
(p < 0.1) at 45 and 60 minutes. The glucose cleared
from the plasma about 30 minutes earlier with the Phaseolamin™
compared to the control. The area under the plasma glucose-time
curve (a measure of glucose absorption and metabolism)
was 85% lower with the Phase 2® , p < 0.05.
Thus only 15% of the glucose in the bread compared to
the control found its way into the body in the presence
of Phase 2® . These results show the effectiveness
of the product in decreasing the absorption of glucose
from complex carbohydrates from this group of subjects.
Chart
#1: Comparison of Phase 2® and Control on
Change in Plasma Glucose in College-Age Subjects
Chart
#2: Comparison of Phase 2® and Control on
Change in Plasma Glucose in 11 Subjects