NCT02488356已完成不适用
Safety and Efficacy of Litramine IQP G-002AS for Weight Loss: A Randomised, Double-blind, Placebo-controlled, Parallel-group Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 主要终点
- Change in body weight from baseline
研究概览
简要总结
Safety and Efficacy of Litramine in weight loss.
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
- Triple (Participant, Care Provider, 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
- •Healthy subjects ≥18 and ≤ 60 years of age
- •Body mass index (BMI) ≥ 25 and ≤35 kg/m2
- •Judged by the Investigator to be in general good health on the basis of medical history
- •Judged by the Investigator to be motivated to lose weight
- •Accustomed to 3 main meals per day
- •Consistent and stable body weight 3 months prior to study enrollment (±5%)
- •Consistent regular physical activity
- •Agree to stop all medications and supplements during the entire length of the study
- •Commitment to adhere to diet and lifestyle recommended for the study
- •Females of child bearing potential must agree to use appropriate birth control methods during the entire study period
- •Stable concomitant medications
- •Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator
排除标准
- •Presence of any active gastrointestinal disease
- •Malabsorption disorders
- •Pancreatitis
- •Stenosis in the GI tract
- •Bariatric surgery/Lapband and bypass surgery
- •Abdominal surgery within 6 months prior to the study
- •Subjects whose weight increases 1.5 pounds from screening to the baseline visit
- •History of eating disorders like bulimia, anorexia nervosa, binge-eating
- •Renal conditions / disease, history of nephrolithiasis
- •Cardiac diseases requiring drug therapy
- •Other serious organ or systemic diseases such as diabetes mellitus, standard laundry list of cardiac diseases
- •Osteoporosis or on medications for osteoporosis
- •Known sensitivity to the ingredients of the study medication
- •Vegetarian or Vegan
- •Daily use of dietary supplement (2 week washout is allowed)
- •Any medication that could influence gastrointestinal functions such as antibiotics, laxatives, opioids, anticholinergics, or anti-diarrheals (must have stopped at least 3 months before study start)
- •Subjects who are pregnant or lactating
- •Any medication or use of products for the treatment of obesity (e.g., Xenical, other fat binder, fat burner, satiety products etc.)
- •Subjects who are currently on carbohydrate and protein diet, or low fat diet
- •More than 3 hours of strenuous physical activity per week
- •History of abuse of drugs, alcohol or medication
- •Smoking cessation within the 6 months prior to this study
- •Subjects unable to understand or follow the study protocol
- •Participation in similar study or weight loss program within 6 months prior to this study
- •Participation in other studies with in the last 4 weeks
结局指标
主要结局
Change in body weight from baseline
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
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