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
Volunteers undertook to maintain their regular habits (such as
sport, or any other habits that could affect the study) and to follow
the Dietician's nutritional advises.
At the beginning (t0) and at the end of the study (t30), weight
of each subject was measured. Fat body mass and lean body mass were
calculated (bioelectric impedance measure method).
At the same time (t0 and t30) a cutaneous echographia was performed
on each subject to determine adipose membrane thickness. Such an
evaluation was performed at trochanter zone in women and at abdominal
zone in men. Waistline, hips circumference and thigh circumferences
were also measured.
Furthermore, at the end of the study, volunteers' opinions concerning
tolerability and efficacy of the products were considered.
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
Phase 2® )
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 14.638 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 vitro 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.
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