NCT02228746已完成不适用
Effect of the Alpha-galacto-oligasaccharides on Weight Loss in Overweight or Moderately Obeses Adults : A Randomized Controlled Double Blinded Trial Versus Placebo
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Olygose
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Body weight (kg) between day 0 and week 12
研究概览
简要总结
Clinical intervention on overweight or moderately obeses adults. The objective of this trial is to demonstrate the superior eficacy of Alphagos to placebo on weight loss during a low-calorie diet of 12 weeks. The superiority is judged on body weight. Change in cardiometabolic risk factors through the intervention have been evaluated as secondary endpoints
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index > or equal 25 and < 35
- •Use of effective contraception in women of childbearing age
排除标准
- •Pregnant women (positive pregnancy test) or breastfeeding
- •Anti-hypertensive or cholesterol treatment
- •HIV infection or HCV
- •Hepatic and/or severe renal failure
- •Heart attack within 6 months prior the selection
- •Heart failure known
- •Inflammatory disease known
- •Cancer or have had cancer within 3 years prior to the study except for basal cell skin cancers
- •Diabetes defined by blood glucose greater than or equal to 1.26 g/L
- •Gastrointestinal disease known
- •Bariatric surgery
结局指标
主要结局
Body weight (kg) between day 0 and week 12
时间窗: Day 0, Day 7, Month 1, Month 2, Month 3
次要结局
- Hip circumference(Day 0, Day 7, Month 1, Month 2, Month 3)
- Feeding behaviour(Between day 0 and week 12)
- Lean body mass(Between day 0 and week 12)
- Waist circumference(Day 0, day 7, Month1, Month 2, Month 3)
- Waist to hip circumference ratio(Between Day 0 and week 12)
- Body Fat(Day 7, Month 3)
研究者
研究点 (2)
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