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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
ClinicalTrials.gov ID: NCT07481578
What this study is testing
- What it's testing
- 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.
- Time commitment: about 8 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, men only. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
See the full eligibility 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.
- 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...
- 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 treatment trial, without approval from the research team.
- Any other reasons considered by the research team that the participant will not complete the study.
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Vlaams Brabant, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Vlaams Brabant, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.