DeBartoloSlim™
Natural, Non-Stimulant Starch Neutralizer
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DESCRIPTION
DeBartoloSlim™
is a dietary supplement containing a unique natural
botanical extract that has been shown in clinical
studies to safely neutralize the conversion of a
significant portion of ingested carbohydrates into
glucose resulting in subsequent reduction of fat
deposition. It is a valuable addition to a weight
management program to help support healthy weight
levels.
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OVERVIEW
Obesity is
a dangerous and prevalent disease in the United States.
Further, the prevalence of obesity in adult Americans has
increased 65% over the past decade. Currently, approximately
60% of adult Americans are either overweight (defined as
having a Body Mass Index (BMI) >25) or clinically obese
(defined as having a BMI > 30). In addition, obesity is
reaching epidemic proportions in adolescents and teens where
approximately 25% of American children are overweight and
about 10-15% are obese. Obesity is linked with an increased
risk of several chronic diseases including coronary artery
disease, dyslipidemia, hypertension, diabetes mellitus,
degenerative arthritis, obstructive apnea, and possibly
asthma. In addition to the health risks, excessive body weight
results in a decreased quality of life including impaired
mobile activity and poor self-esteem. Diet and inactivity are
principal causes of unhealthy weight gain.
Fortunately,
obesity is a treatable disease that responds favorably in many
individuals to appropriate dietary modification and exercise
programs. A modest weight loss (5% of body weight)
significantly decreases the risk of these diseases, especially
diabetes and cardiovascular disease. Although there are
several pharmacologic agents currently used for the treatment
of obesity, these are complicated by undesirable side effects
that may include cardiac valvular disease, hypertension,
seizures, sexual dysfunction, and fecal incontinence. Reaching
and maintaining an appropriate body weight is important for
the reduction of chronic disease risk and improvement of
quality of life.
One
effective approach to weight management is the restriction of
caloric intake under conditions in which all of the essential
nutrients are maintained at an optimal level. Although simple
in theory, caloric restriction is often impractical because of
the instinct to overeat and the difficulty in making
significant changes to dietary food preferences. If caloric
restriction is to be effective, one of the most promising
approaches would be to limit the amount of caloric
contribution from complex carbohydrates (potatoes, rice,
pasta, and breads) since these contribute nearly one-half of
the total calories in the average American diet.
During the
digestive process, the body converts complex carbohydrates
(starches) into sugar. This is accomplished by breaking down
the carbohydrate molecule with alpha
amylase, an enzyme produced in the pancreas and, to a
lesser extent, in the saliva. The resultant sugar molecules
are either burned off through exercise, or stored as fat for
future use. Unfortunately, inactivity means that the stored
fat accumulates over time. The result is weight gain.
An extract
from the white kidney bean (Phaseolus
vulgaris) was demonstrated in 1974 to exert specific
inhibition of alpha amylase activity. However, only recently
has a commercial extract of Phaseolus vulgaris been available that effectively reduces complex
carbohydrate absorption in humans. This extract, Phase 2™
(formerly Phaseolamin 2250™) has been shown to retain about
60-80% of its alpha amylase inhibitory activity after exposure
to gastric and intestinal solutions. In vivo testing shows
that Phase 2™ neutralizes approximately 2,250 complex
carbohydrate calories per gram. Two pilot double-blind
placebo-controlled trials on normal human subjects
demonstrated a 57 to 85% neutralization of starch-derived
calories as determined by plasma glucose responses in test
subjects consuming 1,500 mg of Phase 2™ prior to a
standardized test meal compared to placebo control subjects.
Another double-blind placebo-controlled study was conducted on
60 healthy human subjects (male and female) who were
moderately overweight (12 to 33 pounds above ideal body
weight). Subjects consuming 500 mg of Phase 2™ before one
test meal each day lost an average of almost 6.5 pounds at the
end of the 30-day test period. Subjects on the placebo lost an
average of about 0.3 pounds. In addition, subjects consuming
Phase 2™ had an average weight loss of 6.5 pounds after 30
days with an 11.63% reduction of fat body mass, preservation
of lean muscle mass, and a 3.44% reduction of waistline, a
1.39% reduction of hips circumference, and a 1.44% reduction
of thigh circumference. Subjects on placebo showed minimal
changes in any of these test parameters.
DeBartoloSlim™
provides a safe, non-stimulant approach for weight loss
through fat body mass reduction via reduced digestion
absorption of complex carbohydrates that represents a
significant, or even excessive, proportion of daily caloric
intake. A reduction in carbohydrate absorption will decrease
blood glucose and cholesterol levels. When combined with
sensible dietary modifications and moderate exercise, this can
be an important dietary adjunct for helping reduce excessive
body weight and prevent the onset or progression of
weight-associated chronic disease.
INDICATIONS
DeBartoloSlim™
is intended as a dietary adjunct for individuals who wish to
achieve and
maintain a more optimal body weight.
FORMULA
Amount
Per 2 Capsules
Phase
2™ white kidney bean (Phaseolus
vulgaris L.), dried extract......................
1,000.......................
mg*
Fennel
(Foeniculum vulgare)
seed powder..............
500......................... mg
*Daily
Value not established.
Other
ingredients: VcapsÔ
vegetarian capsule, cellulose, water, silicon dioxide, and
magnesium stearate.
Phase 2™
is a trademark of Pharmachem Laboratories, Kearney, NJ.
SUGGESTED
USE
One to two
capsules before each meal. For best results, take 15 to 30
minutes before
the beginning of each meal.
ADVERSE
REACTIONS AND CONTRAINDICATIONS
None
reported.
DRUG
INTERACTIONS
None
reported.
HOW
SUPPLIED
90 Vcaps™
capsules per bottle with full-bottle shrink-wrap. Packaged 12
bottles per case.
STORAGE
Store in a
cool, dry place (59ºF-85ºF) away from direct light. Keep out
of reach of children.
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REFERENCES
Bo-Linn
GW, Santa Ana CA, Morawski SG, Fordtran JS. Starch
blockers--their effect on calorie absorption from a
high-starch meal. N
Engl J Med 1982 Dec 2;307(23):1413-6.
Hansen
B. Emerging strategies for weight management. Postgrad
Med 2001 Jun Special Report:3-9.
Hensrud
D. Pharmacotherapy for Obesity. Medical
Clinics of North America 2000 March; 84(2).
Hollenbeck
CB, Coulston AM, Quan R, Becker TR, Vreman HJ, Stevenson
DK, Reaven GM. Effects of a commercial starch blocker
preparation on carbohydrate digestion and absorption: in
vivo and in vitro studies. Am
J Clin Nutr 1983 Oct;38(4):498-503.
Nicklas
TA, Baranowski T, Cullen KW, Berenson G. Eating
patterns, dietary quality and obesity.
J Am Coll Nutr
2001 Dec;20(6):599-608.
Layer
P, Zinsmeister AR, DiMagno EP. Effects of decreasing
intraluminal amylase activity on starch digestion and
postprandial gastrointestinal function in humans. Gastroenterology
1986 Jul;91(1):41-8.
Layer
P, Rizza RA, Zinsmeister AR, Carlson GL, DiMagno EP.
Effect of a purified amylase inhibitor on carbohydrate
tolerance in normal subjects and patients with diabetes
mellitus. Mayo Clin Proc 1986
Jun;61(6):442-7.
Lewy
VD, Danadian K, Arslanian S. Determination of body
composition in African-American children: validation of
bioelectrical impedence with dual energy X-ray
absorptiometry. J
Pediatr Endocrinol Metab
1999 May-Jun;12(3):443-8.
Meyer
BH, Muller FO, Grigoleit HG, Clur BK. Inhibition of
starch absorption by tendamistate
(an alpha-amylase inactivator). S
Afr Med J 1983 Aug 20;64(8):284-5.
Mokdad
AH, Serdula MK, Dietz WH, Bowman BA, Marks JS, Koplan
JP. The spread of the obesity
epidemic in the United States. JAMA
1999 Oct 27;282(16):1519-22.
Mokdad
AH, Bowman BA, Ford ES, Vinicor F, Marks JS, Koplan JP.
The continuing epidemics of obesity and diabetes in the
United States. JAMA
2001 Sep 12;286(10):1195-200.
Rea
TD, Heckbert SR, Kaplan RC, Psaty BM, Smith NL, Lemaitre
RN, Lin D. Body mass index and the risk of recurrent
coronary events following acute myocardial infarction. Am
J Cardiol Sep 1;88(5):467-72.
Tiberi,
L. Evaluation of the efficacy and safety of a food
supplement for weight control through
reduced-calorie intake from carbohydrates vs
placebo (double blind test).Unpublished data, EVIC
Italia 2001.
Umoren J, Kies C. Commercial soybean starch blocker consumption: impact on weight gain and on
copper, lead and zinc
status of rats. Plant Foods Hum Nutr 1992 Apr;42(2):135-42.
Vinson
JA. In vivo effectiveness of a starch absorption blocker
in a double-blind placebo-controlled study with normal
human subjects. Unpublished Data, 2001, University of
Scranton.
Vinson
JA. In vivo effectiveness of a starch absorption blocker
in a double-blind placebo-controlled study with normal
college-age subjects. Unpublished Data, 2001, University
of Scranton.
Young
SY, Gunzenhauser JD, Malone KE, McTiernan A. Body mass
index and asthma in the military population of the
northwestern United States. Arch
Intern Med 2001
Jul 9;161(13):1605-11.
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These statements have not been evaluated by the Food and Drug Administration.
This product is not intended to diagnose, treat, cure, or prevent any disease.
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