Double-blind, randomized, placebo-controlled, bicentric clinical investigation to evaluate the benefit and tolerability of Redusure IQP-AK-102 in reducing body weight in overweight and obese subjects

Abstract

Appetite regulation plays an important role in weight management. Dietary fibres can enhance satiety sensation due to their unique physicochemical properties. This study evaluated the benefit and tolerability of Redusure IQP-AK-102, a patent pending fibres composition for achieving weight loss in overweight and obese Caucasians on hypocaloric diet. Eligible subjects were randomized to take either IQP-AK-102 or identical looking placebo with 250 ml of water 30 to 60 min before breakfast, lunch and dinner for 12 weeks. The primary efficacy endpoint of the study was the difference of mean body weight change after 12 weeks, between the IQP-AK-102 and the placebo groups. Other endpoints measured during the study included changes in body composition (body fat mass and body fat content), waist and hip circumferences, food cravings, satiety, as well as safety and tolerability endpoints. A total of 119 subjects, aged between 18 and 65 years old, who were overweight and obese (BMI of 25 to 35 kg/m2) were enrolled and randomized. IQP-AK-102 supplementation demonstrated a significant mean body weight reduction compared to placebo after 12 weeks [3.53 kg (SD 2.28) and 0.14 kg (SD 1.84) respectively, p < 0.001)]. A significant difference in mean body weight reduction was observed as early as after 4 weeks of IQP-AK-102 consumption [1.01 kg (SD 1.43) versus 0.25 kg (SD 1.17) respectively]. Other efficacy endpoints also showed significant differences between the two intervention groups by the end of the study. No clinically significant changes in blood profiles, clinical chemistry and blood pressure were noted throughout the 12-week study. There was no significant difference in the proportion of subjects that reported adverse events in both study groups. Administration of IQP-AK-102 in conjunction with good dietary and exercise habits for 12 weeks promotes significant weight loss in overweight and obese but otherwise healthy subjects. IQP-AK-102 also shows good safety and tolerability profile.

Keywords: Weight loss, satiety, dietary fibre, overweight, obesity.