NCT07481578 Impact of Training Load on the Gut miCrobiome And Its Relation to exeRcise Performance, mUscle Phenotype, and markerS of Overreaching in Healthy Men
| NCT ID | NCT07481578 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stefan De Smet |
| Condition | Exercise |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2024-10-07 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2024-10-07 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion criteria: * Males between 18 and 45 years old. * Recreationally active individuals, with a weekly exercise training volume between one and six hours per week. * Good health status confirmed by a sport medical screening, which includes a sport medical questionnaire and resting electrocardiogram. * Body Mass Index (BMI) between 18.5 and 27.5 kg/m². * Masters the Dutch language. Exclusion criteria: * Engagement in strenuous competitive sports one month prior to or during the study intervention. * Medication and vaccination: Pro- or antibiotic treatment during the past three months, non-steroidal anti-inflammatory drugs (NSAIDs) or cholestyramine during the past month, drugs interfering with intestinal permeability (e.g., prokinetics, laxatives, lubiprostone, loperamide, anti-spasmodics, linaclotide, proton pump inhibitors) during the past month. Vaccinations within one month prior to or during the study intervention. * Blood donations within three months or plasma donation within one month prior to or during the study intervention. * Inflammatory bowel disease (Crohn or colitis ulcerosa) or celiac disease. * Diagnosed irritable bowel syndrome. * Intake of any performance-enhancing medication or nutritional supplements known to modulate the gut microbiome in the two months prior to or during the study. * Substance abuse, including alcohol consumption of more than three units/day (weekly average). * Any injury or pathology considered a contraindication for performing physical exercise, as determined by the medical doctor overseeing the preparticipation medical screening. * No access to smartphone and/or computer with internet access. * No willingness to use the Polar Flow app and MijnEetmeter to collect physical activity, heart rate, sleep, and food intake data. * Concomitant participation in another interventional trial, without approval from the research team. * Any other reasons considered by the research team that the participant will not complete the study.
Contact & Investigator
Stefan De Smet, Professor
PRINCIPAL INVESTIGATOR
Exercise and Muscle Physiology Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium
Frequently Asked Questions
Who can join the NCT07481578 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 45 Years, studying Exercise. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07481578 currently recruiting?
Yes, NCT07481578 is actively recruiting participants. Contact the research team at stefan.desmet@kuleuven.be for enrollment information.
Where is the NCT07481578 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT07481578 clinical trial?
NCT07481578 is sponsored by Stefan De Smet. The principal investigator is Stefan De Smet, Professor at Exercise and Muscle Physiology Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium. The trial plans to enroll 45 participants.