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临床试验/NCT03711383
NCT03711383已完成不适用

The Effects of Inulin on Acetate Production and Human Substrate Metabolism

Maastricht University Medical Center1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年2月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
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 inulin/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

研究组 & 干预措施

Placebo

Placebo Comparator

isocaloric maltodextrin the day before CIDs

干预措施: Placebo (Dietary Supplement)

Inulin and Resistant Starch

Experimental

12 g inulin + 7.5 g resistant starch the day before CID

干预措施: Inulin and Resistant Starch (Dietary Supplement)

Inulin

Active Comparator

12 g of inulin + isocaloric maltodextrin the day before CID

干预措施: Inulin (Dietary Supplement)

结局指标

主要结局

Plasma acetate concentrations (microM)

时间窗: At baseline and up to four hours after a high-fat mixed meal of each CID

次要结局

  • Energy expenditure (in kJ/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)(At baseline and up to four hours after a high-fat mixed meal of each CID)
  • Fat oxidation (in g/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)(At baseline and up to four hours after a high-fat mixed meal of each CID)
  • Carbohydrate oxidation (in g/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)(At baseline and up to four hours after a high-fat mixed meal of each CID)
  • Circulating hormone concentrations (Insulin, GLP-1, PYY)(At baseline and up to four hours after a high-fat mixed meal of each CID)
  • Circulating metabolite concentrations (Glucose, Free Fatty Acids, Triglycerides)(At baseline and up to four hours after a high-fat mixed meal of each CID)
  • Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK)(At baseline and up to four hours after a high-fat mixed meal of each CID)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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