Evaluation of the Bioavailability and Production of Short Chain Fatty Acids in the Colon. A Stable Isotope Study in Healthy Humans.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Concentrations of the short chain fatty acids (acetate, propionate and butyrate) in plasma and urine samples
研究概览
简要总结
The purpose of the study is to evaluate the bioavailability of acetate, propionate and butyrate in healthy humans using a stable isotope technology.
In addition the level of acetate, propionate and butyrate production from inulin will be determined using the principle of isotope dilution.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Regular dietary pattern (3 meals/day)
- •Age: 18-65y
- •BMI: 18,5-27 kg/m2
排除标准
- •Intake of antibiotics 1 month prior to the study
- •Abdominal surgery in the past, with the exception of appendectomy
- •Intake of medication influencing the gastro-intestinal system 14 days prior to the study
- •In treatment at a dietician
- •Intake of pre- and/or probiotics
- •Exposure to radioactivity 1 year prior to the study
- •Serious chronic disease of the gastrointestinal tract
- •Use of medication that affects the gastro-intestinal tract during the last 2 weeks prior to the study
- •Pregnancy, pregnancy desire or lactation
- •Blood donation during the last 3 months prior to the study
- •Diabetes (type 1 or 2)
- •Aberrant hemoglobin level (Hb) in blood. Normal between 14.0 and 18.0 g/dL for men and between 12.0 and 16.0 g/dL for women
结局指标
主要结局
Concentrations of the short chain fatty acids (acetate, propionate and butyrate) in plasma and urine samples
时间窗: 12 hours each test day and 4 test days/volunteer
Participants performed each 4 test days and they were followed each test day for 12 hours, with sample collections at regular time points. Blood samples were collected every hour during the first 4 hours and afterwards every 20 minutes during 8 hours. Urine samples were collected during 24h in different fractions: 0-4h, 4-8h, 8-12h, 12-24h.
次要结局
未报告次要终点