Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
MALE
Healthy Volunteers
NCT07481578

Impact of Training Load on the Gut miCrobiome And Its Relation to exeRcise Performance, mUscle Phenotype, and markerS of Overreaching in Healthy Men

Led by Stefan De Smet · Updated on 2026-03-19

45

Participants Needed

1

Research Sites

138 weeks

Total Duration

On this page

Sponsors

S

Stefan De Smet

Lead Sponsor

K

KU Leuven

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this study is to learn how different amounts of supervised indoor cycling training change gut health (gut bacteria, the substances gut bacteria make, and the gut barrier integrity), and how these changes relate to changes in fitness, muscle health, and signs of doing too much training (a state called 'overreaching'). The study includes healthy, recreationally active men aged 18 to 45 years. The primary questions, for which the study is powered (sufficient participants included), are: 1. Does moderate load training change blood and faecal levels of butyrate (a short-chain fatty acid made by gut bacteria) after eight weeks compared with a control group? 2. Compared to moderate load training, do higher training loads lead to different responses in blood and faecal levels of butyrate? Researchers will compare: * A control group that does not complete structured training; * A moderate-load training group that completes eight weeks of supervised cycling (4x/week); * A high-load training group that completes four weeks of moderate-load training followed by four weeks of higher training load (twice the number of training sessions). Participants will: * Be randomly assigned to one of the three groups; * Complete 8 weeks of supervised indoor cycling sessions if assigned to a training group; * Complete four study assessment periods (baseline, after week four, after week eight, and after a short taper (rest period); * Provide blood, stool, skeletal muscle, urine, saliva, and breath samples during the assessment periods; * Complete fitness and performance tests and questionnaires during the assessment periods.

CONDITIONS

Official Title

Impact of Training Load on the Gut miCrobiome And Its Relation to exeRcise Performance, mUscle Phenotype, and markerS of Overreaching in Healthy Men

Who Can Participate

Age: 18Years - 45Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male between 18 and 45 years old
  • Recreationally active with 1 to 6 hours of exercise weekly
  • Good health confirmed by sports medical screening and resting electrocardiogram
  • Body Mass Index (BMI) between 18.5 and 27.5 kg/m²
  • Fluent in Dutch language
Not Eligible

You will not qualify if you...

  • Participation in strenuous competitive sports within one month before or during the study
  • Use of pro- or antibiotic treatment in the past 3 months
  • Use of NSAIDs or cholestyramine in the past month
  • Use of drugs affecting intestinal permeability in the past month
  • Vaccinations within one month before or during the study
  • Blood donation in the past 3 months or plasma donation in the past month
  • Having inflammatory bowel disease or celiac disease
  • Diagnosed irritable bowel syndrome
  • Use of performance-enhancing medication or supplements affecting gut microbiome in the past 2 months or during study
  • Substance abuse or alcohol intake over three units per day on average
  • Injuries or conditions preventing safe physical exercise
  • No access to smartphone or computer with internet
  • Unwillingness to use apps for tracking physical activity, heart rate, sleep, and food intake
  • Participation in other interventional trials without approval
  • Any other reasons deemed by researchers that participant will not complete the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

Exercise Physiology Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium

Leuven, Vlaams Brabant, Belgium, 3001

Actively Recruiting

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Research Team

S

Stefan De Smet

CONTACT

S

Sofie Engelborghs

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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