Evaluating efficacy of a chitosan product using a double-blinded, placebo-controlled protocol. Decrease in serum LDL cholesterol with microcrystalline chitosan. The effect of the dietary supplement, Chitosan, on body weight: a randomised controlled trial in 250 overweight and obese adults. In the absence of dietary surveillance, chitosan does not reduce plasma lipids or obesity in hypercholesterolaemic obese Asian subjects. A double-blind, placebo-controlled evaluation of the effects of RW94 on the body weight of both overweight and obese healthy volunteers. Randomized, double-blind trial of chitosan for body weight reduction. [Effect of chitosan in complex management of obesity].
To examine the safety and efficacy of a chitosan dietary supplement on body composition under free-living conditions.
                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).
                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.
                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.
                Outcome measures were Dual Energy X-ray Absorptiometry tests, fasting blood chemistries, and self-reported daily activity levels and caloric intakes.
                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).
                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. Peroral microcrystalline chitosan (MCCh; 3 capsules, each 400 mg b.i.d.) or placebo was given for 8 weeks in a double-blind manner to 51 healthy obese women just before routine hospital and home meals. Weight records, serum lipids (total, LDL and HDL cholesterol, triglycerides) and safety laboratory parameters were monitored before the trial and at 4, 6 and 8 weeks of treatment. In a subgroup of subjects with a body mass index > or = 30 who had not changed their eating habits, serum LDL cholesterol decreased 0.57 +/- 0.72 mmol/l (n = ll) at 4 weeks in the MCCh group and 0.10 +/- 0.60 mmol/l (n = 14) in the placebo group (p < 0.05). At 8 weeks, LDL cholesterol reduction was 0.48 +/- 0.91 mmol/l in the MCCh group and 0.26 +/- 0.57 mmol/l in the placebo group (p > 0.1). In all subjects, the reduction in LDL cholesterol at 4 weeks was 0.48 +/- 0.72 mmol/l (n = 24) in MCCh subjects and 0.18 +/- 0.58 mmol/l (n = 27) in placebo subjects (p = 0.057), and 0.52 +/- 0.69 mmol/l and 0.31 +/- 0.63 mmol/l, respectively, at 8 weeks (p > 0.1). MCCh did not significantly alter serum total and HDL cholesterol (p > 0.1), but slightly increased serum triglycerides compared to placebo (p = 0.015-0.06). No reductions in weight were observed in any treatment group. Chitosan was well tolerated and no serious adverse events or changes in safety laboratory parameters were noted including serum fat-soluble vitamins A and E, and serum Fe++ and transferrin. Chitosan, a deacetylated chitin, is a widely available dietary supplement purported to decrease body weight and serum lipids through gastrointestinal fat binding. Although evaluated in a number of trials, its efficacy remains in dispute.
                To evaluate the efficacy of chitosan for weight loss in overweight and obese adults.
                A 24-week randomised, double-blind, placebo-controlled trial, conducted at the University of Auckland between November 2001 and December 2002.
                A total of 250 participants (82% women; mean (s.d.) body mass index, 35.5 (5.1) kg/m(2); mean age, 48 (12) y)
                Participants were randomly assigned to receive 3 g chitosan/day (n=125) or placebo (n=125). All participants received standardised dietary and lifestyle advice for weight loss. Adherence was monitored by capsule counts.
                The primary outcome measure was change in body weight. Secondary outcomes included changes in body mass index, waist circumference, body fat percentage, blood pressure, serum lipids, plasma glucose, fat-soluble vitamins, faecal fat, and health-related quality of life.
                In an intention-to-treat analysis with the last observation carried forward, the chitosan group lost more body weight than the placebo group (mean (s.e.), -0.4 (0.2) kg (0.4% loss) vs +0.2 (0.2) kg (0.2% gain), P=0.03) during the 24-week intervention, but effects were small. Similar small changes occurred in circulating total and LDL cholesterol, and glucose (P<0.01). There were no significant differences between groups for any of the other measured outcomes.
                In this 24-week trial, chitosan treatment did not result in a clinically significant loss of body weight compared with placebo. To investigate the effects of Absorbitol on body weight, anthropometry, body composition, blood pressures and lipid profiles in obese, hypercholesterolaemic subjects without dietary restriction.
                A randomised, double blind. Placebo-controlled study.
                Normal volunteers with no history of chronic illnesses (n=88) who were obese (body fat percentage > 20% in males and > 30% in females) and hypercholesterolaemic (total cholesterol > 5.20 mmol/L). Sixty-eight (72.3%) subjects completed the study.
                After a 4 week run in phase, 4 placebo/Absorbitol (250 mg) capsules were prescribed 3 times a day before meals. Subjects received written information on healthy lifestyle but there was no dietary restriction or monitoring.
                Weight, body mass index, lean body mass, waist, hip, blood pressure, fasting lipids and insulin levels were taken at baseline, 4th and 16th week of the study.
                Analyses were on an intention-to-treat basis. Comparisons between groups were made using Student's t and Mann-Whitney tests for parametric and non-parametric data respectively.
                There was no significant change in the measured parameters in Absorbitol treated subjects compared to those on placebo, with exception of HDL-cholesterol which increased in the absorbitol group and decreased in the placebo group (p=0.048). The side effects of Absorbitol were also comparable to that of placebo.
                In the absence of dietary surveillance, Absorbitol does not bring about improvement in weight, anthropometry, body composition, blood pressure or lipid profile. RW94 is a naturally occurring common inorganic substance and a permitted additive in the food industry which binds to and precipitates free fatty acids in vitro. Our preliminary clinical trial showed a statistically significant increase in the quantity of faecal fat excreted by volunteers who had consumed RW94, showing that the fatty acids were also precipitated and not absorbed in vivo. It is therefore anticipated that RW94 will aid weight loss by preventing the absorption of some of the dietary fat. Five grams of RW94 were administered orally after each main meal to half of a group of 32 overweight or obese, but otherwise healthy, volunteers, the others receiving a placebo of maize starch. There was a statistically significant (p < 0.05) reduction in the mean weights of the RW94 group relative to their controls at three weeks, and this reduction was maintained throughout the remainder of the six-week trial period. In accordance with our previous findings, there was a higher incidence of abdominal discomfort, rumbling stomach and flatulence among the RW94 group, reflecting the possible transient changes in the bacterial ecosystem of the lower gut in response to the increased delivery of nutrients. These adverse events diminished as the bacteria apparently re-established equilibrium. It appears that the incidence of abdominal discomfort in its various forms following consumption of RW94 is lower than that initially indicated in the preliminary study. Thus, this second clinical trial performed under conditions approximating to the 'real life' situation confirmed that RW94 appears to help reduce the increase in weight following the consumption of excessive dietary fat without undue discomfort or inconvenience from adverse sequellae. Overweight and obesity is a prevalent and costly threat to public health. Compelling evidence links overweight and obesity with serious disorders such as cardiovascular diseases and diabetes. Dietary regimen are notoriously burdened with poor compliance. Chitosan is promoted in the US and other countries as an oral remedy to reduce fat absorption and has now been incorporated as a major constituent into several over-the-counter remedies. The primary aim of this study is to investigate the clinical effectiveness of oral chitosan for body weight reduction.
                Thirty-four overweight volunteers were included in a randomized placebo-controlled double-blind trial. Subjects were assigned to receive either four capsules of chitosan or indistinguishable placebo twice daily for 28 consecutive days. Measurements were taken at baseline, after 14 and 28d of treatment. Subjects maintained their normal diet and documented the type and amount of food consumed. Adverse effects were assessed and compliance monitored.
                Data from 30 subjects were entered into an intention-to-treat analysis. After four weeks of treatment, body mass index, serum cholesterol, triglycerides, vitamin A, D, E and beta-carotene were not significantly different in subjects receiving chitosan compared to those receiving placebo. Vitamin K was significantly increased after four weeks in the chitosan group compared with placebo (P<0.05). Compliance was 91.5% and 96.0% for chitosan and placebo groups respectively.
                The above data suggest that chitosan in the administered dosage, without dietary alterations, does not reduce body weight in overweight subjects. No serious adverse effects were reported. The aim of the present study was to verify the effect of chitosan as a possible adjuvant in the complex management of obesity.
                Fifty obese women (22-59 years, BMI > 30) participated in the study. A six months program consisted of 2-hour meetings with a physician, psychologist and dietitian, in a group of about 20 persons, every two weeks. Low calorie diet (1000 kcal/day), physical activity and behaviour modification were recommended. Supplementation with chitosan was evaluated in a randomized, placebo-controlled, double-blind study. In the chitosan group, participants received ChitininN (Primex Ingredients ASA, Avaldsnes, Norway) i.e. 750 mg pure chitosan per tablet, two tablets three times daily before each main meal. The placebo group received identical placebo tablets.
                Significantly higher body weight loss was noted in the chitosan-supplemented group (15.9 kg) than in the placebo group (10.9 kg) Also a greater decrease of systolic and diastolic blood pressure was observed in the chitosan group. There was no difference between the groups in the decrease of LDL and total cholesterol. No adverse effects were noted but the number of drop-outs was higher in the placebo group than in the chitosan group.
                Chitosan can be used as a valuable and safe adjuvant in long-term dietary treatment of obesity. Chitosan seems to accentuate the reduction of blood pressure associated with weight reduction.
There is some evidence that chitosan is more effective than placebo in the short-term treatment of overweight and obesity. However, many trials to date have been of poor quality and results have been variable. Results obtained from high quality trials indicate that the effect of chitosan on body weight is minimal and unlikely to be of clinical significance.