NCT02347293已完成早期 1 期
Indigestible Carbohydrates in an Over-night Design as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Appetite hormones, levels of Peptide YY (PYY) in blood
研究概览
简要总结
The experimental model is a semi-acute, over-night, study where the purpose is to evaluate food factors related to colonially derived regulation and satiety in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal fasting blood glucose
- •BMI 19-25 kg/m2
排除标准
- •Gastrointestinal diseases
- •Food allergies e.g. lactose-, gluten intolerance
- •Metabolic disorder e.g. diabetes
- •Tobacco/snuff users
- •No antibiotic or probiotic intake 2 weeks prior and during study.
- •Vegetarians
结局指标
主要结局
Appetite hormones, levels of Peptide YY (PYY) in blood
时间窗: Postprandial 0-180 min after breakfast
Blood Glucose, levels of glucose in blood
时间窗: Postprandial 0-180 min after breakfast
Insulin, levels of insulin in blood
时间窗: Postprandial 0-180 min after breakfast
Markers of colonic fermentation, levels of hydrogen in breath
时间窗: Postprandial 0-180 min after breakfast
Inflammation markers, levels of Interleukin-6 (IL-6) in blood
时间窗: Postprandial 0-180 min after breakfast
次要结局
- Subjective satiety, as measured by VAS(Postprandial 0-180 min after breakfast)
研究者
Jonna Sandberg
MSc, postgraduate student
Lund University
研究点 (1)
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