NCT01909323已完成不适用
Digestive Tolerance and Postprandial Glycaemic and Insulinaemic Responses Evaluation of Different Maltitol/FOS Mixtures in Healthy Adults
Syral2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2011年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Composite score of gastrointestinal symptoms in the 24h following the consumption of products
研究概览
简要总结
Digestive symptoms following consumption of low digestibe carbohydrates are generally assessed product by product but several ingredients can be used simultaneously. The study aimed at evaluating to digestive tolerance of maltitol and FOS used in a same food.
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
- Triple (Participant, 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
- •BMI between 18.5 and 30
- •normal and regular stool frequency: at least 3 stools per week and no more than 3 per days
- •subjects not sufferinf from a metabolic, functional or inflammatory disease affecting intestinal transit and nutrients absorption
- •subjects not sufferinf from IBS according to Rome III criteria
- •subjects not using mdeiction which could affect nutrients absoprtion
排除标准
- 未提供
研究组 & 干预措施
maltitol alone
Experimental
干预措施: maltitol alone (Other)
sugary dessert cream
Placebo Comparator
干预措施: Placebo (Other)
maltitol 85% / FOS 15%
Experimental
干预措施: maltitol 85% / FOS15% (Other)
maltitol 68% / FOS 32%
Experimental
干预措施: maltitol 68% / FOS 32% (Other)
maltitol 50% / FOS 50%
Experimental
干预措施: maltitol 50% / FOS 50% (Other)
FOS alone
Experimental
干预措施: FOS alone (Other)
结局指标
主要结局
Composite score of gastrointestinal symptoms in the 24h following the consumption of products
时间窗: 24 hours
次要结局
- Individual scores of gastrointestinal symptoms: bloating, abdominal discomfort, borborygms, flatulences(24 and 48 hours)
- Stool frequcency and consistency(24 & 48 hours)
- Glycaemic response(2 hours)
研究者
研究点 (2)
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