Gluten Sensibility in Elite Athletes
GLUTHEALTH
2 other identifiers
interventional
51
1 country
1
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..
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2017
CompletedStudy Start
First participant enrolled
April 1, 2017
CompletedFirst Posted
Study publicly available on registry
April 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2018
CompletedJune 11, 2018
June 1, 2018
12 months
March 9, 2017
June 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Food Benefits Assessment (FBA)
at the beginning of the study, at 2 month and 4 month
Secondary Outcomes (7)
Physicals performances assessment : 3000m running performance
at the beginning of the study, at 2 month and 4 month
Microbiota composition analysis on faeces samples
at the beginning of the study, at 2 month and 4 month
Changes in body composition measured by bioelectrical impedance
at the beginning of the study, at 2 month and 4 month
Qualities life index for digestive disorders modified (GIQLI assessment modified)
at the beginning of the study, at 2 month and 4 month
Inflammatory cytokines
at the beginning of the study, at 2 month and 4 month
- +2 more secondary outcomes
Study Arms (2)
gluten
EXPERIMENTALSelected participants will be randomly allocated to treatment group (gluten or gluten free)
gluten fee
EXPERIMENTALSelected participants will be randomly allocated to treatment group (gluten or gluten free)
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Currently participating or who having got 4500€ in this year before to have participating in another clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- single blind
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2017
First Posted
April 5, 2017
Study Start
April 1, 2017
Primary Completion
March 21, 2018
Study Completion
March 21, 2018
Last Updated
June 11, 2018
Record last verified: 2018-06