Evaluating efficacy of a chitosan product using a double-blinded, placebo-controlled protocol.
OBJECTIVE
To examine the safety and efficacy of a chitosan dietary supplement on body composition under free-living conditions.


METHODS
In a randomized, double-blinded, placebo-controlled dietary intervention protocol, subjects were assigned to a treatment group (TRT), a placebo group (PLA) and a control group (CTL).


METHODS
A total of 150 overweight adults enrolled; 134 (89.3%) completed the study; 111 (82.8%) were women who were similarly distributed in the three groups.


METHODS
The TRT group took six 500 mg chitosan capsules per day and both TRT and PLA groups wore pedometers during their waking hours and recorded daily step totals. The CTL group followed weight loss programs of their choice, and took the same baseline and ending tests.


METHODS
Outcome measures were Dual Energy X-ray Absorptiometry tests, fasting blood chemistries, and self-reported daily activity levels and caloric intakes.


RESULTS
Compared to CTL, the TRT group lost more weight (-2.8 lbs vs. +0.8 lbs, p < 0.001) and fat mass (-2.6 lbs vs. +0.1 lbs, p = 0.006). Compared to PLA, the TRT group lost more weight (-2.8 lbs. vs. -0.6 lbs, p = 0.03), % fat (-0.8% vs. +0.4%, p = 0.003), fat mass (-2.6 lbs vs. +0.6 lbs, p = 0.001) and had a greater body composition improvement index (BCI) (+2.4 lbs vs. -1.9 lbs, p = 0.002).


CONCLUSIONS
These data provide evidence for the efficacy of a chitosan compound to facilitate the depletion of excess body fat under free-living conditions with minimal loss of fat-free or lean body mass.
Kaats
Gilbert R
GR
Health and Medical Research Center, 4940 Broadway, Suite 201, San Antonio, TX 78209, USA. gil@hmrcenter.net
Michalek
Joel E
JE
Preuss
Harry G
HG
D015502:Absorptiometry, Photon; D000328:Adult; D019440:Anti-Obesity Agents / Q000627:therapeutic use*; D001774:Blood Chemical Analysis; D001823:Body Composition / Q000187:drug effects*; D048271:Chitosan / Q000627:therapeutic use*; D004311:Double-Blind Method; D002149:Energy Intake / Q000502:physiology; D015444:Exercise / Q000502:physiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy*; D016896:Treatment Outcome; D015431:Weight Loss / Q000187:drug effects*
D019440:Anti-Obesity Agents; D048271:Chitosan