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临床试验/NCT04795804
NCT04795804已完成不适用

The Effects of Human-like Milk Oligosaccharide and Resistant Starch on Acetate Production and Human Substrate Metabolism

Maastricht University Medical Center2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2020年2月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
2
主要终点
Plasma acetate concentrations.

研究概览

简要总结

The study investigators hypothesize (1) that the SCFA/acetate metabolism differs between metabolic phenotypes and (2) that using a mixture of fibres that differ in degree of polymerization and branching namely a resistant starch and a human-like milk oligosaccharide enhance the acetate availability in the distal colon and systemic circulation, consequently leading to its metabolic effects.

To study this, the investigators will supplement lean, normoglycaemic vs. overweight/obese, prediabetic men with the fibre mixture the day before the clinical investigation day (CID) and study during the CID its effects on fasting and postprandial substrate and energy metabolism.

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Plasma acetate concentrations.

时间窗: plasma acetate will be sampled during the CID at t=240 minutes after consumption of a liquid high fat mixed meal

During the clinical investigation day plasma acetate will be sampled

Faecal acetate concentrations.

时间窗: Fecal acetate will be sampled in the morning before the testday

On the day of clinical investigation day, fecal acetate will be sampled

Plasma butyrate concentrations.

时间窗: plasma butyrate will be sampled during the CID at t=240 minutes after consumption of a liquid high fat mixed meal

During the clinical investigation day, plasma butyrate will be sampled

Fecal butyrate concentrations.

时间窗: Fecal butyrate will be sampled in the morning before the testday

On the day of clinical investigation day, fecal butyrate will be sampled

Plasma propionate concentrations.

时间窗: Plasma propionate will be sampled during the CID t=240 minutes after the consumption of a liquid high fat mixed meal

During the clinical investigation day, plasma propionate will be sampled

Faecal propionate concentrations.

时间窗: Fecal propionate will be sampled in the morning before the testday

On the day of clinical investigation day, fecal propionate will be sampled

次要结局

  • Energy expenditure, fat and carbohydrate oxidation(Indirect calorimetry will be measured before and for 4 hours after the consumption of the liquid high-fat mixed meal during the whole CID)
  • Plasma insulin concentrations(Plasma insulin concentrations will be sampled during the CID before and at t=0, t=30, t=60, t=120 and t=240 minutes after consumption of a liquid high fat mixed meal)
  • Plasma FFA concentrations(Plasma FFA concentrations will be sampled during the CID before and at t=0, t=30, t=60, t=120 and t=240 minutes after consumption of a liquid high fat mixed meal)
  • Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK).(Breath H2 will be sampled during the CID before and at t=30, t=60, t=90, t=120 and t=240 minutes after consumption of a liquid high fat mixed meal)
  • Plasma glucose concentrations(Plasma glucose concentrations will be sampled during the CID before and t=0, t=30, t=60, t=120 and t=240 minutes after consumption of a liquid high fat mixed meal)
  • Faecal microbiota composition(Faecal microbiota composition will be sampled in the morning before the testday)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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