NCT00958529已完成不适用
Effect of Two Doses of Inulin Products on Gastrointestinal Tolerance
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Gastrointestinal Tolerance Score
研究概览
简要总结
The intake of inulin products has been linked to multiple health benefits which has lead to inulin fortification in food products.
The investigators hypothesis that doses of up to 10 grams of inulin products should be well tolerated and not result in a significant increase in gastrointestinal symptoms.
详细描述
0, 5, and 10 grams of inulin
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •english speaking
- •healthy men and women
- •18 and 60 years of age
- •non-smoking
- •non-dieting
- •BMI less than 30
- •standard diet consisting of no more than 15 grams fiber
- •not taking medications
排除标准
- •BMI more than 30
- •Diabetes Mellitus
- •cancer in prior 5 years
- •renal or hepatic disease
- •bacterial infection in past 2 weeks
- •more than 5 kg weight loss in past 3 months
- •history of drug or alcohol abuse in past 6 months
- •use of weight loss, lipid-lowering, anti-hypertensive, or anti- inflammatory medications
- •concurrent or recent intervention study participation
- •consumption of laxatives
- •history of gastrointestinal disorders
- •food allergies
- •pregnant or lactating women
结局指标
主要结局
Gastrointestinal Tolerance Score
时间窗: Aug 2008 thru Oct 2008
次要结局
未报告次要终点
研究者
研究点 (2)
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