A combination of various functional food ingredients as a weight management program: randomized, placebo-controlled, and double-blind human clinical studies

Background: Lycium barbarum increased the postprandial energy expenditure (PPEE). Negative energy balance caused by the systematic procedure (TAIslim ® System), including increasing metabolic rate through physical activity, use of Lycium barbarum-containing TAIslim (Product A), and decreasing caloric intake by consuming a chewable confection (TAIslim SKINNY=Product B), and a meal replacement shake (TAIslim SHAKE=Product C), would be successful for weight loss. Methods: We examined TAIslim System on anthropometrics, appetite in Study 1 and PPEE in Study 2, both in a randomized, placebo-controlled, double-blind manner. 1) A total of 67 participants were randomized into 2 groups (placebo or TAIslim System). Intake procedures were: Product A, 60 ml (20 kcal) b.i.d. immediately before breakfast and lunch, Product B, 1 chew (20 kcal) t.i.d. between meals and after dinner; Product C, 40.5 g (158 kcal) as breakfast. A calorie-restricted diet with multi-vitamin supplementation and daily exercise was required. Anthropometric parameters were assessed at baseline, 4, 8, and 12 w. 2) Appetite was measured using a subjective visual analog scale during the initial 3-7 days of intake. 3) For PPEE evaluation, 12 participants consumed a single bout of TAIslim System products or placebo, and took part in 6 study sessions. EE was measured by an indirect calorimeter immediately before (baseline) and at 1, 2, and 4 h post-intake of samples. Results: 1) Body weight was significantly reduced by 6.2±0.7%, compared to pre-intervention with TAIslim System (P<0.01). Waist circumference, total body fat, blood pressure, and fasting blood glucose levels were also significantly reduced by TAIslim System, in a range of 3.8-9.9%. TAIslim System was significantly more effective than the placebo (P<0.05). The placebo group showed -0.1-3.9% reduction from pre-intervention with no significant difference. 2) TAIslim Functional Foods in Health and Disease 2011; 12:555-573 Page 556 of 573 System also significantly suppressed appetite, by 39%, compared to the baseline and placebo (P<0.05) (11% reduction in the placebo). 3) PPEE was significantly increased by TAIslim System compared to placebo and baseline levels. Compared to the baseline EE, placebo increased only by 0.8±0.9%, but 7.2±1.2 % with TAIslim System (P<0.01). Conclusions: It is suggested that TAIslim System exhibits significant weight loss and stimulating effects on caloric expenditure, and thus may be a useful and effective weight loss program.