Skip to main content
Clinical Trials/NCT04946578
NCT04946578
Unknown
Not Applicable

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

Maastricht University1 site in 1 country34 target enrollmentAugust 24, 2020
ConditionsMicrotia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Microtia
Sponsor
Maastricht University
Enrollment
34
Locations
1
Primary Endpoint
Time to Exhaustion
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 24, 2020
End Date
September 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fred Troost

Principal Investigator

Maastricht University

Eligibility Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Time to Exhaustion

Time Frame: From baseline to end of the study (up to max 45 days)

Time on cycle ergometer until exhaustion

Secondary Outcomes

  • 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))

Study Sites (1)

Loading locations...

Similar Trials