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 significantly (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.