NCT01718431已完成早期 1 期
Prebiotics as Means to Modulate Colonic Events, With the Purpose to Increase Beneficial Effects on Metabolism, Satiety and Cognition.
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Area under the plasma concentration versus time curve (AUC) of the test meal
研究概览
简要总结
This study aims at investigating the impact of colonic fermentation of intrinsic indigestible carbohydrates in cereal whole kernels after three days consumption, on metabolic variables and cognition. The study is performed in healthy, normal to slightly over-weight test subjects.
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 19-28 kg/m2
排除标准
- •gastrointestinal diseases
- •metabolic disorders
- •tobacco/snuff user
- •antibiotic/probiotic treatment
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC) of the test meal
时间窗: Post-prandially after breakfast, 0-150 min
The differences in AUC between different risk markers, assessed in plasma or serum,after intake of the test meal in comparison to the reference meal is measured. Example of variables measured are glucose, insulin, appetite hormones, inflammatory markers, markers of colonic fermentation.
次要结局
- Cognitive performance(Post-prandially after breakfast, 0-210 min)
- Subjective satiety(post-prandially after breakfast, 0-150 min)
研究者
Elin Johansson
MSc, postgraduate student
Lund University
研究点 (2)
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