Gluten Sensibility in Elite Athletes (GLUTHEALTH)

June 8, 2018 updated by: University Hospital, Clermont-Ferrand
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..

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: gluten
Selected participants will be randomly allocated to treatment group (gluten or gluten free)
Behavioral: Gluten
Selected participants will be randomly allocated to treatment group (gluten or gluten free).
EXPERIMENTAL: gluten fee
Selected participants will be randomly allocated to treatment group (gluten or gluten free)
Behavioral: Gluten free
Selected participants will be randomly allocated to treatment group (gluten or gluten free).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Food Benefits Assessment (FBA)
Time Frame: at the beginning of the study, at 2 month and 4 month
at the beginning of the study, at 2 month and 4 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physicals performances assessment : 3000m running performance
Time Frame: at the beginning of the study, at 2 month and 4 month
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
Microbiote composition will be measured by qPCR, targeting 16S gene
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
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
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
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
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
Their reactivity will be studied in the presence of three different forms of gliadins: native, deaminated and hydrolysed
at the beginning of the study, at 2 month and 4 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2017

Primary Completion (ACTUAL)

March 21, 2018

Study Completion (ACTUAL)

March 21, 2018

Study Registration Dates

First Submitted

March 9, 2017

First Submitted That Met QC Criteria

March 30, 2017

First Posted (ACTUAL)

April 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 11, 2018

Last Update Submitted That Met QC Criteria

June 8, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-308
  • 2016-A00356-45 (OTHER: 2016-A00356-45)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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