search
Back to results

Gluten Sensibility in Elite Athletes (GLUTHEALTH)

Primary Purpose

Intestinal Diseases, Gluten-sensitive

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Gluten
Gluten free
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intestinal Diseases focused on measuring Gluten, sport performance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

gluten

gluten fee

Arm Description

Selected participants will be randomly allocated to treatment group (gluten or gluten free)

Selected participants will be randomly allocated to treatment group (gluten or gluten free)

Outcomes

Primary Outcome Measures

Food Benefits Assessment (FBA)

Secondary Outcome Measures

Physicals performances assessment : 3000m running performance
Microbiota composition analysis on faeces samples
Microbiote composition will be measured by qPCR, targeting 16S gene
Changes in body composition measured by bioelectrical impedance
Qualities life index for digestive disorders modified (GIQLI assessment modified)
Inflammatory cytokines
Bone and joint cytokines
Immune function from lymphocytes
Their reactivity will be studied in the presence of three different forms of gliadins: native, deaminated and hydrolysed

Full Information

First Posted
March 9, 2017
Last Updated
June 8, 2018
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
search

1. Study Identification

Unique Protocol Identification Number
NCT03101410
Brief Title
Gluten Sensibility in Elite Athletes
Acronym
GLUTHEALTH
Official Title
Gluten Sensibility in Elite Athletes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
March 21, 2018 (Actual)
Study Completion Date
March 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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..
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Diseases, Gluten-sensitive
Keywords
Gluten, sport performance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
single blind
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gluten
Arm Type
Experimental
Arm Description
Selected participants will be randomly allocated to treatment group (gluten or gluten free)
Arm Title
gluten fee
Arm Type
Experimental
Arm Description
Selected participants will be randomly allocated to treatment group (gluten or gluten free)
Intervention Type
Behavioral
Intervention Name(s)
Gluten
Intervention Description
Selected participants will be randomly allocated to treatment group (gluten or gluten free).
Intervention Type
Behavioral
Intervention Name(s)
Gluten free
Intervention Description
Selected participants will be randomly allocated to treatment group (gluten or gluten free).
Primary Outcome Measure Information:
Title
Food Benefits Assessment (FBA)
Time Frame
at the beginning of the study, at 2 month and 4 month
Secondary Outcome Measure Information:
Title
Physicals performances assessment : 3000m running performance
Time Frame
at the beginning of the study, at 2 month and 4 month
Title
Microbiota composition analysis on faeces samples
Description
Microbiote composition will be measured by qPCR, targeting 16S gene
Time Frame
at the beginning of the study, at 2 month and 4 month
Title
Changes in body composition measured by bioelectrical impedance
Time Frame
at the beginning of the study, at 2 month and 4 month
Title
Qualities life index for digestive disorders modified (GIQLI assessment modified)
Time Frame
at the beginning of the study, at 2 month and 4 month
Title
Inflammatory cytokines
Time Frame
at the beginning of the study, at 2 month and 4 month
Title
Bone and joint cytokines
Time Frame
at the beginning of the study, at 2 month and 4 month
Title
Immune function from lymphocytes
Description
Their reactivity will be studied in the presence of three different forms of gliadins: native, deaminated and hydrolysed
Time Frame
at the beginning of the study, at 2 month and 4 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

Learn more about this trial

Gluten Sensibility in Elite Athletes

We'll reach out to this number within 24 hrs