Double-blind, Randomized, Placebo-controlled Clinical Investigation to Evaluate the Safety and Efficacy of Litramine in Maintaining Body Weight Loss in Overweight and Obese Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean Change in Body Weight From Baseline to End of 24 Weeks
研究概览
简要总结
The effect of Litramine on weight loss has previously been studied during a 12-week intervention period with promising results. The present study looks into the effect of weight maintenance using Litramine following initial weight loss, for a longer period of 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Documented weight loss, achieved over the last 3 to 6 months either from participation in weight loss clinical trials or weight loss regimens, of at least 3% at the point of screening
- •BMI 25-35 before initial weight loss
- •Documented compliance (according to the investigator's judgement) to previous weight loss clinical trials/ regimens
排除标准
- •Known sensitivity to the ingredients of the device (citric acid, acacia or Fabaceae family)
- •BMI < 18.5
- •Presence of other factor(s) that, in the investigator's judgement, should preclude subject participation
研究组 & 干预措施
Placebo
Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal)
干预措施: Placebo (Dietary Supplement)
Litramine
Fibre complex of plant origin n tablet form 2 tablets 3 times daily (oral consumption, after meal)
干预措施: Litramine (Dietary Supplement)
结局指标
主要结局
Mean Change in Body Weight From Baseline to End of 24 Weeks
时间窗: 24 weeks
Change in body weight at the end of 24 weeks measured in kg using a calibrated scale. (positive values signify weight gain, while negative values signify weight reduction
次要结局
- Full Blood Count(24 weeks)
- Waist and Hip Circumference (cm)(24 weeks)
- Body Mass Index (kg/m^2)(24 weeks)
- Blood Pressure(24 weeks)