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临床试验/NCT04946578
NCT04946578Unknown不适用

Modulation of the Intestinal Microbiome, and Its Effects on Endurance Exercise Capacity in Moderately Trained Individuals

Maastricht University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2020年8月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
34
试验地点
1
主要终点
Time to Exhaustion

研究概览

简要总结

The aim of this study is to investigate the effect of a six-week period personalised food intervention with prebiotic supplementation on intense exercise performance in healthy, recreationally active adults.

详细描述

The study conforms to a randomized, single-blinded, placebo-controlled parallel study design.

a prebiotic supplement will be selected based on a participants gut microbiota. 1 sachet of prebiotic or placebo will be given twice a day over a period of 6 weeks.

Before the start of the study, a VO2max test will be performed. Subjects will bring faecal samples which is collected at home. A time to exhaustion of approximately 80% of their VO2max will be performed at baseline and after the 6 weeks intervention period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Male or female 18 - 40 y
  • •BMI range 18.5 - 25 kg/m2
  • •Recreational active (performing non-competitive physical endurance exercise at least two times per week with a minimum duration of 60 minutes per exercise bout)

排除标准

  • •Performing regular resistance training (3+ times per week, carrying out progressive overload training)
  • •Subject following an overly imbalanced or restrictive diet as per nutritional advice
  • •Participants who received antibiotics in the 90 days prior to the start of the study
  • •Self-admitted lactose intolerance
  • •Administration of probiotic or prebiotic supplements in the 14 days prior to the study

研究组 & 干预措施

Prebiotic intervention group

Experimental

Prebiotic supplementation

干预措施: Prebiotic (Dietary Supplement)

Placebo control group

Placebo Comparator

Maltodextrin

干预措施: Placebo (Other)

结局指标

主要结局

Time to Exhaustion

时间窗: From baseline to end of the study (up to max 45 days)

Time on cycle ergometer until exhaustion

次要结局

  • Insulin(From baseline to end of the study (up to max 45 days))
  • Plasma short chain fatty acids(From baseline to end of the study (up to max 45 days))
  • Gut microbiota composition(From baseline to end of the study (up to max 45 days))
  • Blood glucose(From baseline to end of the study (up to max 45 days))
  • Intestinal permeability by sugar test(From baseline to end of the study (up to max 45 days))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fred Troost

Principal Investigator

Maastricht University

研究点 (1)

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