Exploring the Relationship Between the Gut Microbiome, Physical Fitness Levels and Metabolic Resp… (NCT05220657) | Clinical Trial Compass
CompletedNot Applicable
Exploring the Relationship Between the Gut Microbiome, Physical Fitness Levels and Metabolic Responses to Exercise
France50 participantsStarted 2022-01-20
Plain-language summary
Gut microbiota are all microorganisms including bacteria and microscopic eukaryotes that live in the digestive tracts of humans or mammals. During the last decade, some authors highlighted that a link exists between gut microbiota and sport performance. In this project, we hypothesize that gut microbiota is able to adapt to the energy needs of the body, really higher in top-level athletes or considerably lower in inactive individuals. In this context, this clinical study aims to characterize the bacterial metagenome of gut microbiota from populations located in a continuum from sedentary people to top-level athletes with high (i.e. soccer players), even very high energy needs (i.e. cyclists). The finality of this project is thus to determine if it exists some bacterial profile allowing to characterize, even to predict, the energy metabolism of an athlete and so the probability to be performant in competition.
Who can participate
Age range
18 Years – 30 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* BMI between 18 and 25 kg/m²
* Non-smoker
* Written informed consent
Exclusion Criteria:
* Cardiovascular risks
* Metabolic diseases (e.g. diabetes)
* Use of antibiotics, anti-fungi or anti-parasites in the last 3 months or during participation in the study
* Use of prebiotics and / or probiotics in the form of supplements in the 7 days preceding the start of the study (greater than or equal to 100000000 Colony Forming Units or organisms per day)
* Taking drug treatment for chronic pain management (paracetamol, vasodilator, homeopathy, aspirin greater than 500 mg per day)
* Simultaneous participation in another research involving the human person or having recently participated in another research for which the exclusion period has not been completed.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.