CompletedNot Applicable

Gluten Sensibility in Elite Athletes

France51 participantsStarted 2017-04-01

Plain-language summary

This clinical project aims to study the relationship between gluten consumption and its impact on digestive comfort, quality of life and performance of non-celiac athletes practicing an intensive physical activity..

Who can participate

Age range

18 Years

Sex

ALL

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: * Male and female trained \>7h/week or more of 5 training/week * Member of a sports federation or medical certificate fewer 3 months * VO2 max estimated \>125% of the theoretical value * Regular consumption of gluten under different products * Healthy (apparently free of diseases) and without any medical treatment * Without digestive diseases and non-coeliac disease * Affiliated to National Health Insurance * Having normal capacity of training to enter in the study procedures * Having provided her written informed consent Exclusion Criteria: * Medicals or surgical histories, evaluated non compatible by the investigator * Diseases known * Antibiotherapy 2 months before the study * Gluten-free diet * Individual unable to give informed consent or refusing to sign informed consent * Being in exclusion on the National Volunteers Data file or refusing to be registered on the National Volunteers Data file * Currently participating or who having got 4500€ in this year before to have participating in another clinical trial

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.

What they're measuring

Food Benefits Assessment (FBA)

Timeframe: at the beginning of the study, at 2 month and 4 month

Trial details

NCT IDNCT03101410

SponsorUniversity Hospital, Clermont-Ferrand

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-03-21

View on ClinicalTrials.gov More Intestinal Diseases trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.