NCT02796989已完成1 期
The Impact of Modified Wheat Bran on Carbohydrate Fermentation in the Colon in Healthy and Obese Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The incremental plasma short-chain fatty acid concentrations will be measured using GC-FID after an intervention with wheat bran/placebo
研究概览
简要总结
During this project the effect of modified wheat bran on colon health and systemic health will be evaluated in a long-term intervention study in healthy and obese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 18 and 65 years old
- •BMI between 18 and 25 kg/m² OR higher than 30 kg/m²
- •Regular diet
- •Not dieting
排除标准
- •Use of antibiotics in the month preceding the study
- •Diabetes Type 1 or 2
- •Abdominal surgery (except from appendectomy)
- •Use of medication that affects the gastrointestinal tract during the last 2 weeks prior to the study including spasmolytics, anti-diarrhoea medication, anti-constipation medication
- •Use of pre- or probiotic supplements in the month preceding the study
- •Chronic gastrointestinal diseases, such as inflammatory bowel disease (Crohn's disease, ulcerative colitis), irritable bowel disease...
- •Pregnancy or lactation
- •Blood donation in the last 3 months
- •Abnormal Hb-level (Standard range between 14 and 18 g/dL for men and between 12 and 16 g/dL for women)
- •Participation in clinical studies involving radiation exposure in the past year
结局指标
主要结局
The incremental plasma short-chain fatty acid concentrations will be measured using GC-FID after an intervention with wheat bran/placebo
时间窗: 1 month
次要结局
- Gut permeability using 51-Cr-EDTA(1 month)
- Changes in gut microbiota before and after the intervention using 16S rRNA sequencing(1 month)
- Changes in glucose levels (mg/dL)(1 month)
- Changes in cholesterol levels (mg/dL)(1 month)
- Changes in free fatty acids levels (mmol/L)(1 month)
- Changes in triglyceride levels (mg/dL)(1 month)
- Total gastrointestinal transit time(1 month)
- Changes in insulin levels (pmol/L)(1 month)
- Changes in metabolite patterns in the feces before and after the intervention using gas chromatography coupled to mass spectrometry(1 month)
研究者
Kristin Verbeke
Professor Kristin Verbeke
KU Leuven
研究点 (2)
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