Uebelhack Ralf, Bongartz Udo, Seibt Stephanie, Bothe Gordana, Chong Pee Win, De Costa Patricia, Wszelaki Natalia
analyze & realize GmbH, Weißenseer Weg 111, 10369 Berlin, Germany.
analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany.
J Obes. 2019 Feb 3;2019:3412952. doi: 10.1155/2019/3412952. eCollection 2019.
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.
A double-blind, randomized, placebo-controlled trial involved one hundred and eight subjects (BMI between 25 and 35 kg/m) 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.
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; < 0.001) and the low-dose group (3.01 ± 2.19 kg; =0.001). The high-dose group experienced a decrease in body fat of 3.15 ± 2.41 kg compared with a decrease of 0.23 ± 2.74 kg for the placebo group ( < 0.001). High-dose IQP-AE-103 also decreased the feeling of hunger in 66% subjects. A beneficial effect of IQP-AE-103 on the lipid metabolism was also demonstrated in the subgroup of subjects with baseline total cholesterol levels above 6.2 mmol/L. No side effects related to the intake of IQP-AE-103 were reported.
These findings indicate that IQP-AE-103 could be an effective and safe weight loss intervention. This trial is registered with NCT03058367.
本研究旨在确定IQP-AE-103对超重至中度肥胖成年人减轻体重的疗效和耐受性/安全性。
一项双盲、随机、安慰剂对照试验纳入了108名受试者（BMI在25至35kg/m之间），他们被随机分配到低剂量或高剂量IQP-AE-103组或安慰剂组。在为期2周的导入期后，受试者在每日三餐后服用两粒试验产品胶囊，持续12周。受试者被要求根据个人能量需求保持营养均衡的低热量饮食。在基线以及2、4、8和12周后测量体重、体脂、腰围和臀围。受试者还使用视觉模拟量表对饥饿和饱腹感进行评分，并在相同时间间隔内用5分制对食物渴望程度进行评分。在研究开始前和结束时采集血样检测安全实验室参数。
摄入12周后，高剂量IQP-AE-103组的体重减轻显著大于安慰剂组（分别为5.03±2.50kg和0.98±2.06kg；P<0.001）以及低剂量组（3.01±2.19kg；P=0.001）。与安慰剂组体脂减少0.23±2.74kg相比，高剂量组体脂减少3.15±2.41kg（P<0.001）。高剂量IQP-AE-103还使66%的受试者饥饿感降低。在基线总胆固醇水平高于6.2mmol/L的受试者亚组中，也证明了IQP-AE-103对脂质代谢有有益作用。未报告与摄入IQP-AE-103相关的副作用。
这些发现表明IQP-AE-103可能是一种有效且安全的减肥干预措施。本试验已在ClinicalTrials.gov上注册，注册号为NCT03058367。
