Practice for General Medicine, Berlin, Germany.
Obesity (Silver Spring). 2014 Mar;22(3):645-51. doi: 10.1002/oby.20577. Epub 2013 Sep 5.
The safety and efficacy of IQP-PV-101, a proprietary extract of Phaseolus vulgaris, on weight management in two phases was evaluated here. The weight loss (WL) phase was conducted over 12 weeks and the weight maintenance (WM) phase took 24 weeks.
In the double-blind WL phase, subjects were randomized to receive either IQP-PV-101 or placebo. All subjects adhered to a mildly hypocaloric diet. Body weight and other body composition parameters were measured at baseline and every 4 weeks thereafter. During the single arm, open label WM trial, energy intake was ad libitum. Efficacy parameters were measured at baseline, week 12 and week 24.
At the end of the WL study, the IQP-PV-101 group lost a mean of 2.91 ± 2.63 kg in body weight compared with 0.92 ± 2.00 kg in the placebo group (P < 0.001). During the WM phase, 36 out of 49 subjects (73.5%) were able to maintain their weight, even without dietary restrictions. No serious or related adverse events were reported over the combined period of 36 weeks.
Results indicate that IQP-PV-101 is safe and effective for weight loss and maintenance.
在此评估 IQP-PV-101（菜豆专有提取物）在两个阶段的体重管理中的安全性和有效性。减肥（WL）阶段持续 12 周，体重维持（WM）阶段持续 24 周。
在双盲 WL 阶段，受试者随机接受 IQP-PV-101 或安慰剂。所有受试者均遵循低热量饮食。在基线和此后的每 4 周测量体重和其他身体成分参数。在单臂、开放标签 WM 试验期间，能量摄入为随意。在基线、第 12 周和第 24 周测量疗效参数。
在 WL 研究结束时，IQP-PV-101 组的体重平均减轻 2.91±2.63 公斤，而安慰剂组仅减轻 0.92±2.00 公斤（P<0.001）。在 WM 阶段，49 名受试者中有 36 名（73.5%）即使没有饮食限制也能够维持体重。在 36 周的联合期间，未报告任何严重或相关的不良事件。
结果表明 IQP-PV-101 安全且有效，可用于减肥和维持体重。
