Dietrine™ Phase 2® Clinical Studies
Clinical Studie 1
In vivo effectiveness of a starch absorption blocker in a double-blind placebo-controlled study with normal subjects.
Joe A. Vinson, PhD, Donna M. Shuta, BS and Hassan Al Kharrat, MS
Department of Chemistry
University of Scranton
Scranton, PA 18510
Analysis data were obtained from the first study done
reported on September 6, 2001 and the second study on November, 20,
2001. The total subjects from both studies numbered 20. Nine were
excluded who did not furnish all blood samples or who had a negative
area for the plasma glucose-time curve and were therefore poor absorbers.
Of the 11 subjects, 8 were female and 3 were male, ranging in age
from 21 to 57. The Dietrine Phase 2® group had significantly lower plasma
glucose at 60 minutes and almost significantly lower glucose at
45 minutes. The area of the curve (area above the baseline which
is 0 to 62 minutes for Dietrine Phase 2® and 0 to 80 minutes for the
control), which represents glucose absorption and metabolism, was
66% smaller with Dietrine Phase 2®.
This product shows effectiveness in both sedentary college-age
subjects and physically active adults.
Clinical Studie 2
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
Dietrine 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 Dietrine Phase 2® group occurred at 30 minutes.
This dose of Dietrine 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 Dietrine Phase 2®. These results show the effectiveness of the product
in decreasing the absorption of glucose from complex carbohydrates
from this group of subjects.
Clinical Studie 3
Dietrine Phase 2® Demonstrates Efficacy When Taken With a Mixed Full Meal
University of Scranton researcher, Prof. Joe A. Vinson,
reports that Dietrine Phase 2® reduced starch absorption by 28% when
0.75 grams of the ingredient was mixed with a full meal and served
to participants in a random, blinded fashion. Three previous human
pilot trials conducted by Vinson confirmed that 1.5 grams of Phase
2® were effective in reducing starch calories (an average of
66%) when study participants were fed a high carbohydrate, high
fat meal of bread and margarine.
"This study is important because it shows that half the amount
of Dietrine Phase 2® can be effective in a full meal containing carbohydrates,
proteins and fat," said Vinson. "It is also consistent
with previous studies. An even more significant difference in starch
absorption may occur if respondents are given a higher dose of Phase
2®".
The study involved seven participants who consumed a microwaved
control meal consisting of Hungry-Man Frozen Country Fried Beef
Steak, along with 240 ml of water. The meal contained 630 calories
with 64 grams of carbohydrates, 29 grams of protein, and 29 grams
of fat in the form of breaded sirloin beef patties, mashed potatoes
with gravy, mushrooms, green beans, and cherry-apple crumb cake.
The control group received only the meal, while the other group
received the meal with 0.75 grams of Dietrine Phase 2® mixed in with
the mashed potatoes.
Clinical Studie 4
Starch Neutralizer Promotes Weight Loss, Lowers Triglyceride Levels
KEARNY, NJ, DEC. 10, 2002 — Patients who took
a concentrated starch neutralizer extracted from the white kidney
bean, lost nearly a half pound per week (3.8 lbs. over eight weeks),
on average, or better than 200% more than those on placebo. Patients
on the starch neutralizer also lost 1.5 inches around their waists,
on average, or 43% more than those on placebo.
“The results are encouraging, and look very promising,”
said chief researcher, Jay Udani, M.D., Medical Director, Integrative
Medicine Program, Northridge Hospital Medical Center, Los Angeles,
CA.
“One of the most surprising results of the study was the
impact that the starch neutralizer had on triglycerides, a form
of bad cholesterol,” said Udani. “There was a dramatic,
26-point drop in triglyceride levels, on average, for patients taking
the starch neutralizer, while those on placebo averaged only an
8 point drop in triglyceride levels. The difference between the
two groups was more than 300%.
“The ability of this product to reduce triglycerides may be
an important adjunct in maintaining a good cardiac profile.”
Another surprising result, according to Udani, was the effect of
the starch neutralizer on energy levels.
“Those patients on the starch neutralizer reported a 13%
increase in energy, while those on placebo reported no improvement
in this area. This is important because the starch neutralizer is
not a stimulant.”
No significant adverse effects from the starch neutralizer were
reported by any of the patients participating in the study.
Pharmachem laboratories, Kearny, NJ, is the supplier of Dietrine Phase 2®
starch neutralizer. The company develops, supplies and manufactures
a variety of high-quality, efficacious food supplements standardized
for specific potency, solubility, direct compression and disintegration
characteristics. The Company operates four processing and manufacturing
facilities in Northern New Jersey, including the H. Reisman Corporation.
Pharmachem also owns American Ingredients, Anaheim, CA.
Clinical Studie 5
Investigation of the efficacy of Dietrine Phase 2® a purified bean extract from Pharmachem Laboratories
Joe A. Vinson, Ph.D.
Department of Chemistry
University of Scranton
Background
Amylase is a digestive tract enzyme, which breaks down starch into
small units capable of being further degraded to glucose, which
is used for fuel for normal metabolism and body homeostasis. Clinical
use of inhibitors of amylase activity has widespread appeal because
a controlled reduction of starch digestion could influence carbohydrate
uptake in diabetes and obesity, the latter of which is a current
problem with 20% of the US population. Of course obesity is also
linked to a greater risk of diabetes. A search in the National Library
of Medicine Database reveals that there are 1098 articles concerning
amylase inhibition. About 15 years ago there were a number of articles
concerning the use of commercial bean-derived extracts. Also there
were several articles indicating that some of these products, which
were good in vitro inhibitors, were not effective when given to
humans. Possible reasons for this failure were 1) insufficient activity;
2) destruction in the gastrointestinal tract; 3) suboptimal pH conditions;
and 3) different gastric emptying rates of starch and inhibitor.
A comprehensive experimental investigation by a group at the Mayo
Clinic in 1985 found that the major reason commercial bean amylase
inhibitors have failed to influence starch digestion in humans is
their low antiamylase activity. Some inhibitors also have side effects
such as diarrhea and an increase in intestinal gas. We have investigated
the effectiveness of a new commercial bean extract (Dietrine Phase 2®)
prepared by Pharmachem Laboratories using normal human subjects.
Protocol
Five males and five females (ages 21 to 57) participated
in a double-blind placebo controlled crossover study with informed
consent. All subjects were employees at a commercial clinical laboratory
and went about their duties as secretaries and technicians during
the study. After an overnight fast, the participants were sampled
for blood and then given in a random manner either 1) placebo consisting
of 4 slices of white bread (60 grams of carbohydrate), 42 grams
of soybean oil margarine and 4 grams of Sweet N'Low spread on the
bread; 2) experimental comprising the placebo plus 1.5 grams of
Dietrine Phase 2® prepared by Pharmachem Laboratories. Plasma glucose
was measured by a commercial enzyme kit (Sigma Chemical Company),
from blood drawn at baseline every 30 minutes for 4 hours. After
1 week the regimen was repeated with the other supplement.
Results and Discussion
The subjects were normoglycemic as measured by fasting
glucose concentration, which averaged 98 mg/dl for the placebo and
104 for the Dietrine Phase 2®. From 60 to 120 minutes (as seen in the
accompanying figure) the change in plasma glucose of the Phaseolamin™
group from the baseline was ½ to 1/3 of the level of the
placebo group. Phaseolamin™ consumption caused the plasma
glucose to return to baseline values 20 minutes earlier than the
placebo without Phaseolamin™. The average area under the plasma
glucose-time curve from 0 to 150 minutes, which is a measure of
absorption and metabolism, was 57% lower with Phaseolamin™.
Plotting the average change in glucose concentration from 30 minutes
to 210 minutes, the area under the curve was positive for the placebo
but negative for Dietrine Phase 2®. This indicates that very little
of the glucose from the starch in the bread was absorbed when co-ingested
with Phase 2® and the glucose was cleared very rapidly. No side
effects were observed with this product. The promising positive
preliminary results of this single dose pilot study need to be confirmed.
More control of physical activity is required to decrease the variability
of plasma glucose between subjects. Ingestion of Dietrine Phase 2®.ith
a conventional meal should be examined. Other groups such as diabetic
and obese should be studied with a single dose and also in a long-term
supplementation study.
 Clinical Studie 6
Summary of clinical study evaluating effectiveness of Dietrine Phase 2®.
Dr. R. Ballerini,
Managing Director of Pharmeceutical Development and Service srl.
Milano, Italy
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
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
Dietrine 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.
Clinical Studie 7
Chronic Toxicity Study Confirms Safety of Dietrine Phase 2® Ingredient
KEARNY, NJ, NOV. 5, 2002 - Pharmachem Laboratories,
Inc., today announced that a Chronic Toxicity Study (L.D.50) demonstrated
that Dietrine Phase 2 Starch Neutralizer™, the first standardized white
bean extract used in a variety of weight loss supplements, is safe
and non-toxic.
“Dietrine Phase 2® showed no signs of chronic toxicity at doses
up to 1.0 gm/kg body weight for up to 90 days,” said Ramadasan
Kuttan, Ph.D., director, Amala Cancer Research Center, Thrissur,
India, who conducted the study along with R. C. Srimal, M.D. “The
data indicates that administration of Phase 2® for 90 days did
not produce any adverse reaction as seen from the organ weight,
necropsy, haematological values and biochemical values.”
Additional findings of the study were as follows:
- There was no significant weight changes in any of the animals.
- Food consumption in the Dietrine Phase 2® groups (1 gm and 5
gm) was found to be decreased significantly, especially after two
months of treatment, compared to controls.
- Liver function tests indicated that chronic administration
of Dietrine Phase 2® at the doses given did not produce any change in
the liver function tests such as GOT, GPT, ALP, Bilirubin, total
protein and Albumin/Globulin ratio.
- Chronic administration of the Dietrine Phase 2® did not produce
any change in the renal function as indicated from serum urea, creatinine
and electrolyte levels.
- Chronic administration of Dietrine Phase 2® did not produce any
change in the haematological parameters such as total WBC, differential
count and platelets.
- There was no change in necroscopy of the animals and organ
weight of the animals such as liver, kidney, spleen were unchanged.
- There was no significant change in the lipid profile of
animals treated with Dietrine Phase 2®
- Histopathology of liver and kidney of the Dietrine Phase 2® treated
groups was normal and similar to controls.
An LD 50 study for acute toxicity, conducted earlier this year,
also confirmed that Dietrine Phase 2® is “safe and non-toxic.”
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