Double-Blind, Randomized, Three-Armed, Placebo-Controlled, Clinical Investigation to Evaluate the Benefit and Tolerability of Two Dosages of IQP-AE-103 in Reducing Body Weight in Overweight and Moderately Obese Subjects

• Published in: Journal of obesity 2019-01, Vol.2019 (2019), p.1-12
• Main Authors: Wszelaki, Natalia, Chong, Pee-Win, Bothe, Gordana, Seibt, Stephanie, Bongartz, Udo, Uebelhack, Ralf, De Costa, Patricia
• Format: Article
• Language: English
• Subjects: Abelmoschus - chemistry; Adult; Anti-Obesity Agents - pharmacology; Body mass index; Body Weight - drug effects; Cardiovascular disease; Cholesterol; Clinical Study; Diabetes; Diet; Diet, Reducing; Dietary Supplements; Double-Blind Method; Double-blind studies; Fecal incontinence; Feces; Female; Humans; Inulin - pharmacology; Liver diseases; Male; Metabolism; Microbiota; Middle Aged; Nutrition research; Obesity; Obesity - drug therapy; Obesity - physiopathology; Oils & fats; Overweight - drug therapy; Overweight - physiopathology; Phytotherapy; Public health; Sleep apnea; Treatment Outcome; Weight control; Weight Loss - drug effects; Weight Loss - physiology; Womens health; Young Adult
• ISSN: 2090-0708; 2090-0716; 2090-0716
• DOI: 10.1155/2019/3412952

Objective. This study was performed to determine the efficacy and tolerability/safety of IQP-AE-103 on body weight reduction in overweight to moderately obese adults. Methods. A double-blind, randomized, placebo-controlled trial involved one hundred and eight subjects (BMI between 25 and 35 kg/m2) that were randomly assigned to either the low-dose or the high-dose IQP-AE-103 group, or the placebo group. Following a 2-week run-in period, subjects received two capsules of investigational product after three daily main meals for 12 weeks. Subjects were instructed to maintain a nutritionally balanced hypocaloric diet according to the individual’s energy requirement. Body weight, body fat, and waist and hip circumference were measured at baseline, and after 2, 4, 8, and 12 weeks. Subjects also rated their feelings of hunger and fullness using visual analogue scales, and food craving on a 5-point scale at the same time intervals. Blood samplings for safety laboratory parameters were taken before and at the end of the study. Results. After 12 weeks of intake, the high-dose IQP-AE-103 group had a significantly greater weight loss compared with the placebo (5.03 ± 2.50 kg vs. 0.98 ± 2.06 kg, respectively; p