NCT05220657

Brief Summary

Gut microbiota are all microorganisms including bacteria and microscopic eukaryotes that live in the digestive tracts of humans or mammals. During the last decade, some authors highlighted that a link exists between gut microbiota and sport performance. In this project, we hypothesize that gut microbiota is able to adapt to the energy needs of the body, really higher in top-level athletes or considerably lower in inactive individuals. In this context, this clinical study aims to characterize the bacterial metagenome of gut microbiota from populations located in a continuum from sedentary people to top-level athletes with high (i.e. soccer players), even very high energy needs (i.e. cyclists). The finality of this project is thus to determine if it exists some bacterial profile allowing to characterize, even to predict, the energy metabolism of an athlete and so the probability to be performant in competition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

January 20, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2022

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

9 months

First QC Date

January 17, 2022

Last Update Submit

January 9, 2023

Conditions

Keywords

Physical activityCarbohydrates and lipid metabolismsGut microbiotaMaximal oxygen consumption

Outcome Measures

Primary Outcomes (1)

  • Gut microbiota composition

    Whole metagenomic sequencing using shotgun approach

    week 1

Secondary Outcomes (6)

  • Gut microbiota function

    Week 1

  • Short chain fatty acids levels in stools

    week 1

  • Amino acids levels in stools

    week 1

  • Maximal oxygen consumption (VO2max)

    Week 2

  • Lipid oxidation during physical exercise

    week 3

  • +1 more secondary outcomes

Study Arms (4)

Low active subjects

No intervention

Diagnostic Test: Maximal incremental exercise testDiagnostic Test: Submaximal exercise test

Moderately active subjects

No intervention

Diagnostic Test: Maximal incremental exercise testDiagnostic Test: Submaximal exercise test

Elite soccer players

No intervention

Diagnostic Test: Maximal incremental exercise testDiagnostic Test: Submaximal exercise test

Elite cyclists

No intervention

Diagnostic Test: Maximal incremental exercise testDiagnostic Test: Submaximal exercise test

Interventions

Gas exchanges are measured during all the test on ergocycle until oxygen consumption reach its maximum value

Elite cyclistsElite soccer playersLow active subjectsModerately active subjects

A 25-min submaximal exercise test on ergocycle under fasting condition. Gas exchanges are measured during all the test.

Elite cyclistsElite soccer playersLow active subjectsModerately active subjects

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Populations located in a continuum from inactive people to top-level athletes with high (i.e. soccer players) and very high energy needs (i.e. cyclists).

You may qualify if:

  • BMI between 18 and 25 kg/m²
  • Non-smoker
  • Written informed consent

You may not qualify if:

  • Cardiovascular risks
  • Metabolic diseases (e.g. diabetes)
  • Use of antibiotics, anti-fungi or anti-parasites in the last 3 months or during participation in the study
  • Use of prebiotics and / or probiotics in the form of supplements in the 7 days preceding the start of the study (greater than or equal to 100000000 Colony Forming Units or organisms per day)
  • Taking drug treatment for chronic pain management (paracetamol, vasodilator, homeopathy, aspirin greater than 500 mg per day)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Rennes 2 - Laboratory "Movement, Sport and health Sciences"

Bruz, Brittany Region, 35170, France

Location

Related Publications (5)

  • Nay K, Jollet M, Goustard B, Baati N, Vernus B, Pontones M, Lefeuvre-Orfila L, Bendavid C, Rue O, Mariadassou M, Bonnieu A, Ollendorff V, Lepage P, Derbre F, Koechlin-Ramonatxo C. Gut bacteria are critical for optimal muscle function: a potential link with glucose homeostasis. Am J Physiol Endocrinol Metab. 2019 Jul 1;317(1):E158-E171. doi: 10.1152/ajpendo.00521.2018. Epub 2019 Apr 30.

    PMID: 31039010BACKGROUND
  • Clarke SF, Murphy EF, O'Sullivan O, Lucey AJ, Humphreys M, Hogan A, Hayes P, O'Reilly M, Jeffery IB, Wood-Martin R, Kerins DM, Quigley E, Ross RP, O'Toole PW, Molloy MG, Falvey E, Shanahan F, Cotter PD. Exercise and associated dietary extremes impact on gut microbial diversity. Gut. 2014 Dec;63(12):1913-20. doi: 10.1136/gutjnl-2013-306541. Epub 2014 Jun 9.

    PMID: 25021423BACKGROUND
  • Barton W, Penney NC, Cronin O, Garcia-Perez I, Molloy MG, Holmes E, Shanahan F, Cotter PD, O'Sullivan O. The microbiome of professional athletes differs from that of more sedentary subjects in composition and particularly at the functional metabolic level. Gut. 2018 Apr;67(4):625-633. doi: 10.1136/gutjnl-2016-313627. Epub 2017 Mar 30.

    PMID: 28360096BACKGROUND
  • Voorhies AA, Mark Ott C, Mehta S, Pierson DL, Crucian BE, Feiveson A, Oubre CM, Torralba M, Moncera K, Zhang Y, Zurek E, Lorenzi HA. Study of the impact of long-duration space missions at the International Space Station on the astronaut microbiome. Sci Rep. 2019 Jul 9;9(1):9911. doi: 10.1038/s41598-019-46303-8.

    PMID: 31289321BACKGROUND
  • Allen JM, Mailing LJ, Niemiro GM, Moore R, Cook MD, White BA, Holscher HD, Woods JA. Exercise Alters Gut Microbiota Composition and Function in Lean and Obese Humans. Med Sci Sports Exerc. 2018 Apr;50(4):747-757. doi: 10.1249/MSS.0000000000001495.

    PMID: 29166320BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Frozen stool suspension

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Frédéric DERBRÉ, PhD

    Laboratory of Movement, Sport and health Sciences (M2S)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 17, 2022

First Posted

February 2, 2022

Study Start

January 20, 2022

Primary Completion

October 26, 2022

Study Completion

November 23, 2022

Last Updated

January 10, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations