NCT01590667已完成4 期
Double-blind, Randomized, Placebo-controlled, Crossover Clinical Investigation to Evaluate the Effect of Litramine on Fecal Fat Excretion in Healthy Subjects
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Difference between Litramine and placebo in changes of percentage fecal fat excretion after intervention
研究概览
简要总结
The study aims to evaluate the effect of Litramine on fecal fat excretion in healthy subjects, to provide more comprehensive and robust clinical evidence in its mode of action for the treatment of obesity and weight management through dietary fat binding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •BMI 20-30 kg/m2
- •Accustomed to 3 main meals/day
- •Commitment to avoid the use of other weight management products during study
- •Females' agreement to use appropriate birth control methods during the active study period
- •Self-reported regular bowel movement (1-2 times per day)
- •Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply
排除标准
- •Known sensitivity to the ingredients of the device
- •Diabetes mellitus (type 1 or 2)
- •History or clinical signs of endocrine disorders
- •Clinically relevant excursions of safety parameter
- •Current use of anti-depressants
- •Presence of acute or chronic gastrointestinal disease
- •Uncontrolled hypertension (more than 160/110 mm Hg)
- •Stenosis in the gastrointestinal tract
- •Bariatric surgery
- •Abdominal surgery within the last 6 months prior to enrollment
- •History of eating disorders such as bulimia, anorexia nervosa within the past 12 months
- •Other serious organ or systemic diseases such as cancer
- •Any medication that could influence gastrointestinal functions
- •Pregnancy or nursing
- •Any medication or use of products for the treatment of obesity within 6 weeks prior to enrolment
- •History of abuse of drugs, alcohol or medication
- •Presence of other factor(s) that, in the investigator's judgment, should preclude subject participation
结局指标
主要结局
Difference between Litramine and placebo in changes of percentage fecal fat excretion after intervention
时间窗: 7 days per intervention
The amount of fat excreted in the feces will be quantified by the near-infrared reflectance analysis (NIRA)
次要结局
- Full blood count(Approximately 45 days)
- Clinical chemistry(Approximately 45 days)
- Blood pressure(Approximately 45 days)
研究者
研究点 (2)
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