LipoSan Ultra® - Scientific
Documentation
A Randomized, Double-Blind,
Placebo-Controlled Study Examining the Effects of a Rapidly
Soluble Chitosan Dietary Supplement on Weight Loss and Body
Composition in Overweight and Mildly Obese Individuals
Rebecca N. Schiller, MS, CN, Eleanor Barrager, RD,
Alexander G. Schauss, PhD, Everett J. Nichols, MSPH, PhD
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ABSTRACT
Goal: The goal of this study is to evaluate the efficacy of a
rapidly-soluble chitosan (LipoSan Ultra™) in facilitating weight loss
and reducing body fat in overweight and mildly obese individuals
consuming a high-fat diet. This study also examines functional changes
in gastrointestinal and elimination symptoms caused by supplementation
of this compound.
Methods: 59 overweight, mildly obese, otherwise healthy females with a
history of daily dietary fat consumption greater than or equal to 30% of
total calories participated in a randomized double-blind
placebo-controlled trial. Subjects received either three capsules of a
rapidly soluble chitosan (LipoSan Ultra™) or matched placebo twice daily
for eight weeks. Supplementation was divided
into two doses, 1.5 g each, and was taken just prior to the two largest
meals of the day. No food restrictions or modifications were assigned,
and subjects were instructed to continue their regular caloric intake.
Dietary calorie and fat intake was monitored during the study by
three-day diet diaries completed at baseline and at weeks four and
eight. Anthropometric measurements and functional gastrointestinal and
elimination symptoms were measured at baseline and week eight.
Results: Mean weight, body mass index (BMI), and percent body fat
increased significantly in the placebo group as compared to baseline
(p<0.01, 0.001, and 0.05 respectively); additionally, percent lean body
mass decreased significantly within the placebo group (p<0.005). Within
the treatment group, both mean weight and BMI decreased significant
(p<0.005 and 0.05 respectively) compared to baseline. The mean weight
loss within the treatment group was 1.0 kg over an 8 week period. This
was in contrast to the placebo group which experienced a mean weight
gain of 1.5 kg over the same time period. When comparing study groups,
endpoint values for mean weight and BMI were significantly higher in the
placebo group (p<0.0001 and 0.01 respectively). Chi-square analysis for
weight loss between groups indicates significantly more subjects lost
weight within the treatment group than within the placebo group (63% and
17 respectively, p<0.001). No significant changes in functional
gastrointestinal and elimination symptoms occurred in either group.
Conclusion: Our findings suggest that this rapidly-soluble chitosan
(LipoSan Ultra™) is efficacious in facilitating weight loss and reducing
body fat in overweight and mildly obese individuals. In addition, we
found no significant changes in gastrointestinal and elimination
symptoms with the use of this polysaccharide biopolymer. |
