NCT01387126撤回3 期
A Randomized, Controlled Trial Evaluating the Effects of a High Viscosity Dietary Fibre, as Part of a Medically Supervised Weight Management Program, on Body Weight in Overweight and Obese Individuals
Canadian Center for Functional Medicine2 个研究点 分布在 1 个国家开始时间: 2011年7月4日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Body weight
研究概览
简要总结
The aim of this study is to investigate whether the supplementation of a medically supervised weight management program with a novel fibre supplement, improves body weight, body composition, and laboratory measurements in overweight and obese individuals. All subjects will participate in the medical weight management program however the intervention group will have 5 grams of a novel fibre supplemented to each meal while the control group will not.
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
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI 27 - 30 Kg/m2 with 1 weight-related comorbidity and/or BMI 30 - 50 Kg/m2
- •Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation in English
排除标准
- •Medications and supplements that affect body weight and appetite
- •Type 2 diabetes on insulin treatment
- •Contraindications to low calorie diet
- •Any allergies to study product ingredients
- •Any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the protocol.
研究组 & 干预措施
Novel fibre supplement
Experimental
The full dose of the study intervention is 15 grams per day.
干预措施: Novel fibre supplement (Dietary Supplement)
Weight management program
No Intervention
结局指标
主要结局
Body weight
时间窗: 52 weeks
次要结局
- Body composition(52 weeks)
研究者
研究点 (2)
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