NCT03714646已完成不适用
The Effects of Beta Glucan on Acetate Production and Human Substrate Metabolism
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Plasma acetate concentrations (microM)
研究概览
简要总结
Based on our hypothesis that orally administered resistant starch and beta glucan will be fermented into a SCFA pattern high in acetate and that this will lead to beneficial effects on human substrate and energy metabolism, we aim to address the following primary objective:
To investigate the effects of an acute administration of inulin/beta glucan in combination with resistant starch on fecal and plasma acetate, as well as on fasting and postprandial substrate and energy metabolism in lean normoglycemic men and obese, prediabetic men.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •lean (BMI ≥ 20kg/m2 and ≤ 24.9kg/m2)
- •normoglycemic
- •aged 30 - 65 years
- •overweight/obese (BMI ≥ 25kg/m2 and ≤ 34.9kg/m2)
- •pre-diabetes
- •aged between 30 - 65 years.
排除标准
- •diabetes mellitus
- •gastroenterological diseases or major abdominal surgery (allowed i.e.: ---appendectomy, cholecystectomy)
- •lactose intolerance and other digestive disorders
- •cardiovascular disease, cancer, liver or kidney malfunction (determined based on ALAT and creatinine levels, respectively)
- •disease with a life expectancy shorter than 5 years
- •Use of antibiotics 3 months prior inclusion
- •Use of probiotics or prebiotics
结局指标
主要结局
Plasma acetate concentrations (microM)
时间窗: four hours after a high fat mixed meal
次要结局
- Energy expenditure (kJ/min) will be measured using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)(at baseline and four hours after a high fat mixed meal)
- Circulating hormone concentrations (Insulin, GLP-1, PYY)(at baseline and four hours after a high fat mixed meal)
- Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK)(at baseline and four hours after a high fat mixed meal)
- carbohydrate oxidation (g/min) will be measured using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)(at baseline and four hours after a high fat mixed meal)
- fat oxidation (g/min) will be measured using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)(at baseline and four hours after a high fat mixed meal)
- Circulating metabolite concentrations (Glucose, Free Fatty Acids, Triglycerides)(at baseline and four hours after a high fat mixed meal)
- Plasma glucose (mmol/L)(at baseline and four hours after a high fat mixed meal)
- Free Fatty Acids (micromol/L)(at baseline and four hours after a high fat mixed meal)
研究者
研究点 (2)
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