Intestinal DiseasesGLUTHEALTHNCT03101410
Gluten Sensibility in Elite Athletes
A study testing Gluten and Gluten free in people with Intestinal Diseases and Gluten-sensitive, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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.. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intestinal Diseases, Gluten-sensitive
- What is being tested?
- Gluten and Gluten free
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2017to 21 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Affiliated to National Health Insurance
- Having normal capacity of training to enter in the study procedures
- Having provided her written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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..
Read the detailed description
Gluten is a protein network that results from both, the hydration and the kneading of storage proteins contained in the endosperm of certain cereals. Gluten is particularly found in bread products but it is also found in many processed products because of its physicochemical properties (binding, swelling properties ...). This omnipresence is now blamed, and a growing percentage of the population reports "intolerance" to gluten. This gluten sensitivity hypothesis is frequently associated with intestinal disorders (irritable bowel syndrome, bloating, abdominal pain, chronic diarrhea, constipation) but also with headache, fatigue, muscle and joint aches, bone fragility, migraine, eczema, depression, anxiety .... This assumption has led to the adoption of increasingly frequent gluten-free diets among the general population, without medical justification.
Among the population, athletes are particularly concerned due to a higher prevalence of anaphylaxis dependent on the combination of physical exercise and food intake (Maulitz and Kidd syndrome). This syndrome is notably reported with consumption of cereals in particular wheat (bread, pasta). However, these conditions are poorly described with regards to gluten and scientific investigations are required to rationally characterize the benefits of gluten-free diets for elite athletes.
Therefore, 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.
All the participants will give freely their written informed consent before their selection in the study.
Information on physical activities, demographics, anthropometrics, vital signs, relevant medical history and concomitant medication, dietary habits, usual dietary intake and nutritional supplements will be collected. All inclusion and exclusion criteria will be checked by the investigator or co-investigator.
Selected participants will be randomly allocated to treatment group (gluten or gluten free). Couple from the same family will be randomised in the same group.
After 2 months, all subjects will have the diet without gluten.
All recruited volunteers will be asked to replace their bread and pasta intake by study products (pasta and white bread with or without gluten), maintain their usual dietary habits and continue their normal physical habits.
Each 2 months, volunteers will have a physical performance assessment and will provide a blood and faeces samples. All volunteers will complete a follow-up questionnaire to obtain information about any changes in medication use, disease etc. Each week, all subjects will complete a questionnaire related to digestive function :Food Benefits Assessment (FBA)).
At the beginning and 2 months, usual dietary intakes will be estimated by means of a 3- days food records.
- Conditions
- Intestinal Diseases, Gluten-sensitive
- Being tested
- Gluten, Gluten free
- Keywords
- Gluten, sport performance
- Medical subject headings
- Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutenBehavioural
Selected participants will be randomly allocated to treatment group (gluten or gluten free).
Gluten freeBehavioural
Selected participants will be randomly allocated to treatment group (gluten or gluten free).
| Study group | Role | What they receive |
|---|---|---|
| gluten | Experimental | Selected participants will be randomly allocated to treatment group (gluten or gluten free) Receives: Behavioral: Gluten |
| gluten fee | Experimental | Selected participants will be randomly allocated to treatment group (gluten or gluten free) Receives: Behavioral: Gluten free |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Benefits Assessment (FBA)
Measured: at the beginning of the study, at 2 month and 4 month
Secondary outcomes (7)
Physicals performances assessment : 3000m running performance
Measured: at the beginning of the study, at 2 month and 4 month
Microbiota composition analysis on faeces samples
Microbiote composition will be measured by qPCR, targeting 16S gene
Measured: at the beginning of the study, at 2 month and 4 month
Changes in body composition measured by bioelectrical impedance
Measured: at the beginning of the study, at 2 month and 4 month
Qualities life index for digestive disorders modified (GIQLI assessment modified)
Measured: at the beginning of the study, at 2 month and 4 month
Inflammatory cytokines
Measured: at the beginning of the study, at 2 month and 4 month
Bone and joint cytokines
Measured: at the beginning of the study, at 2 month and 4 month
Immune function from lymphocytes
Their reactivity will be studied in the presence of three different forms of gliadins: native, deaminated and hydrolysed
Measured: at the beginning of the study, at 2 month and 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start1 Apr 2017
- Primary completion21 Mar 2018
- Study completion21 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intestinal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Institut Carnot Qualiment
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101410
- Sponsor's protocol ID
- CHU-308
- Other IDs
- 2016-A00356-45
- Acronym
- GLUTHEALTH
- Status last verified
- Aug 2026
- First submitted
- 9 Mar 2017
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Delmas E, Bingula R, Del'homme C, Meunier N, Caille A, Lyon-Belgy N, Richard R, Do Couto MG, Wittrant Y, Bernalier-Donadille A. A Low-Gluten Diet Reduces the Abundance of Potentially Beneficial Bacteria in Healthy Adult Gut Microbiota. Nutrients. 2025 Jul 22;17(15):2389. doi: 10.3390/nu17152389.
PubMed 40805974
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gluten Sensibility in Elite Athletes
- ClinicalTrials.gov ID
- NCT03101410
- Acronym / sponsor ID
- GLUTHEALTH / CHU-308
- Conditions
- Intestinal Diseases, Gluten-sensitive
- Keywords
- Gluten, sport performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Institut Carnot Qualiment
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 21 Mar 2018 (actual)
- Study completion
- 21 Mar 2018 (actual)
- First posted
- 5 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Detailed description
Gluten is a protein network that results from both, the hydration and the kneading of storage proteins contained in the endosperm of certain cereals. Gluten is particularly found in bread products but it is also found in many processed products because of its physicochemical properties (binding, swelling properties ...). This omnipresence is now blamed, and a growing percentage of the population reports "intolerance" to gluten. This gluten sensitivity hypothesis is frequently associated with intestinal disorders (irritable bowel syndrome, bloating, abdominal pain, chronic diarrhea, constipation) but also with headache, fatigue, muscle and joint aches, bone fragility, migraine, eczema, depression, anxiety .... This assumption has led to the adoption of increasingly frequent gluten-free diets among the general population, without medical justification.
Among the population, athletes are particularly concerned due to a higher prevalence of anaphylaxis dependent on the combination of physical exercise and food intake (Maulitz and Kidd syndrome). This syndrome is notably reported with consumption of cereals in particular wheat (bread, pasta). However, these conditions are poorly described with regards to gluten and scientific investigations are required to rationally characterize the benefits of gluten-free diets for elite athletes.
Therefore, 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.
All the participants will give freely their written informed consent before their selection in the study.
Information on physical activities, demographics, anthropometrics, vital signs, relevant medical history and concomitant medication, dietary habits, usual dietary intake and nutritional supplements will be collected. All inclusion and exclusion criteria will be checked by the investigator or co-investigator.
Selected participants will be randomly allocated to treatment group (gluten or gluten free). Couple from the same family will be randomised in the same group.
After 2 months, all subjects will have the diet without gluten.
All recruited volunteers will be asked to replace their bread and pasta intake by study products (pasta and white bread with or without gluten), maintain their usual dietary habits and continue their normal physical habits.
Each 2 months, volunteers will have a physical performance assessment and will provide a blood and faeces samples. All volunteers will complete a follow-up questionnaire to obtain information about any changes in medication use, disease etc. Each week, all subjects will complete a questionnaire related to digestive function :Food Benefits Assessment (FBA)).
At the beginning and 2 months, usual dietary intakes will be estimated by means of a 3- days food records.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gluten | Experimental | Behavioral: GlutenSelected participants will be randomly allocated to treatment group (gluten or gluten free) |
| gluten fee | Experimental | Behavioral: Gluten freeSelected participants will be randomly allocated to treatment group (gluten or gluten free) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlutenSelected participants will be randomly allocated to treatment group (gluten or gluten free). | Behavioural | gluten |
| Gluten freeSelected participants will be randomly allocated to treatment group (gluten or gluten free). | Behavioural | gluten fee |
Primary outcome
Food Benefits Assessment (FBA)
Time frame: at the beginning of the study, at 2 month and 4 month
7 secondary outcomes
Physicals performances assessment : 3000m running performance
Time frame: at the beginning of the study, at 2 month and 4 month
Microbiota composition analysis on faeces samples
Time frame: at the beginning of the study, at 2 month and 4 month
Changes in body composition measured by bioelectrical impedance
Time frame: at the beginning of the study, at 2 month and 4 month
Qualities life index for digestive disorders modified (GIQLI assessment modified)
Time frame: at the beginning of the study, at 2 month and 4 month
Inflammatory cytokines
Time frame: at the beginning of the study, at 2 month and 4 month
Bone and joint cytokines
Time frame: at the beginning of the study, at 2 month and 4 month
Immune function from lymphocytes
Time frame: at the beginning of the study, at 2 month and 4 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Results publication: PubMed 40805974Delmas E, Bingula R, Del'homme C, Meunier N, Caille A, Lyon-Belgy N, Richard R, Do Couto MG, Wittrant Y, Bernalier-Donadille A. A Low-Gluten Diet Reduces the Abundance of Potentially Beneficial Bacteria in Healthy Adult Gut Microbiota. Nutrients. 2025 Jul 22;17(15):2389. doi: 10.3390/nu17152389.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten and Gluten free in people with Intestinal Diseases and Gluten-sensitive, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food Benefits Assessment (FBA) (time frame: at the beginning of the study, at 2 month and 4 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03101410, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.