Characterization of the Gut Microbiota Signature According to Physical Fitness and Its Implications for Intestinal Health.

NCT07276464 | Recruiting DMC

• 1 other identifier: 2025-A01645-44
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The gut microbiota comprises all microorganisms inhabiting the digestive tract, evolving throughout life under the influence of various intrinsic and extrinsic factors. Under healthy conditions, the microbiota remains stable, resilient, and maintains a symbiotic relationship with its host. Conversely, dysbiosis refers to an alteration in microbial composition and function, which has been linked to diseases such as inflammatory bowel disease (IBD). IBD, including Crohn's disease and ulcerative colitis, is associated with a disrupted microbiota compared to healthy individuals, leading to impaired intestinal barrier integrity and activation of local inflammatory pathways. Increasing evidence also suggests that the gut microbiota of athletes differs from that of physically inactive individuals, showing greater microbial diversity and higher concentrations of short-chain fatty acids (SCFAs). In this context, the present clinical study aims to characterize the bacterial metagenome of the gut microbiota across a continuum ranging from inactive individuals to elite athletes with high or very high energy demands. The ultimate goal of this project is to determine whether specific gut microbiota composition and functional profiles are associated with different levels of exercise capacity, and to create a fecal microbiota biobank for future research on intestinal health.

Conditions

Healthy

Keywords

Physical activity; Gut microbiota; Intestinal health; exercise capacity; colitis

Outcome Measures

Primary Outcomes (1)

• Gut microbiota composition (α-diversity)

  The primary outcome measure will be α-diversity (i.e., Shannon index) assessed from fecal samples collected from each participant. This index will serve as the main criterion to detect gut microbiota remodeling associated with training status and key parameters of aerobic performance. After transforming the continuous quantitative variables into discrete variables according to standardized performance scales, we will evaluate whether statistical differences exist in α-diversity between the defined groups using comparative statistical analyses (parametric or non-parametric depending on data distribution). This approach aims to identify associations between gut microbial biodiversity, training status, and aerobic performance, with the broader goal of exploring microbial signatures potentially beneficial to intestinal health.

  Week 1

Secondary Outcomes (2)

• β-diversity (i.e., differences between samples)

  Week 1

• Establish a fecal biobank

  Week 1

Study Arms (3)

Low to moderate active subjects

V̇O₂max : 40-50 ml/min/kg

Diagnostic Test: Maximal incremental exercise test; Diagnostic Test: Submaximal exercise test; Biological: Fecal sampling

Trained subjects

V̇O₂max : 50-65 ml/min/kg

Diagnostic Test: Maximal incremental exercise test; Diagnostic Test: Submaximal exercise test; Biological: Fecal sampling

Highly trained subjects

V̇O₂max \> 65 ml/min/kg

Diagnostic Test: Maximal incremental exercise test; Diagnostic Test: Submaximal exercise test; Biological: Fecal sampling

Interventions

Maximal incremental exercise test DIAGNOSTIC_TEST

Participants will perform this test on a cycle ergometer. Gas exchange will be continuously measured throughout the test, and blood lactate will be sampled at regular intervals until maximal oxygen consumption is reached.

Highly trained subjects; Low to moderate active subjects; Trained subjects

Submaximal exercise test DIAGNOSTIC_TEST

A 25-min submaximal exercise test on ergocycle under fasting condition. Gas exchanges are measured during all the test and blood lactate will be sampled at regular intervals.

Highly trained subjects; Low to moderate active subjects; Trained subjects

Fecal sampling BIOLOGICAL

Fecal samples will be collected in order to (1) conduct metagenomic and metabolomic analyses to characterize the gut microbiota composition and function, and (2) create a fecal biobank for future research involving fecal microbiota transplantation in mice.

Highly trained subjects; Low to moderate active subjects; Trained subjects

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Populations located in a continuum from inactive people to top-level athletes with high and very high exercise capacity.

You may qualify if:

• Male participant
• Aged between 18 and 30 years (inclusive)
• Body Mass Index (BMI) between 18 and 25 kg/m² (inclusive)
• No history of gastrointestinal disease, including inflammatory bowel disease
• Be a non-smoker.
• Have a regular bowel transit (1-2 bowel movements per day or every other day) without recurrent episodes of diarrhea or constipation
• Having provided free, informed, and written consent to participate in the study
• Training status :
• Low to moderate active subjects : Perform 2 to 4 hours per week of moderate to vigorous physical activity (VO₂max between 40 and 50 mL·min-¹·kg-¹).
• Trained subjects : Perform 5 to 7 hours per week of regular endurance training for at least one year (VO₂max between 50 and 65 mL·min-¹·kg-¹).
• Highly trained subjects : Perform at least 10 hours per week of structured endurance training, with daily or twice-daily sessions (VO₂max greater than 65 mL·min-¹·kg-¹).

You may not qualify if:

• History of cardiovascular disease.
• Presence of a metabolic disorder (e.g., diabetes).
• Use of antibiotics, antifungal, or antiparasitic agents within the past 3 months, or planned use during participation in the study.
• Use of prebiotic and/or probiotic supplements within the 7 days preceding the study, providing ≥10⁸ CFU or organisms per day.
• Current use of medication for chronic pain management, including paracetamol, vasodilators, homeopathic treatments, or aspirin at doses \>500 mg/day.

Sponsors & Collaborators

• University of Rennes 2: lead

Study Sites (1)

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

Bruz, Britanny, 35170, France

RECRUITING

Related Publications (8)

• Martin D, Bonneau M, Orfila L, Horeau M, Hazon M, Demay R, Lecommandeur E, Boumpoutou R, Guillotel A, Guillemot P, Croyal M, Cressard P, Cressard C, Cuzol A, Monbet V, Derbre F. Atypical gut microbial ecosystem from athletes with very high exercise capacity improves insulin sensitivity and muscle glycogen store in mice. Cell Rep. 2025 Apr 22;44(4):115448. doi: 10.1016/j.celrep.2025.115448. Epub 2025 Mar 27.

  PMID: 40154488 RESULT

• Mohr AE, Jager R, Carpenter KC, Kerksick CM, Purpura M, Townsend JR, West NP, Black K, Gleeson M, Pyne DB, Wells SD, Arent SM, Kreider RB, Campbell BI, Bannock L, Scheiman J, Wissent CJ, Pane M, Kalman DS, Pugh JN, Ortega-Santos CP, Ter Haar JA, Arciero PJ, Antonio J. The athletic gut microbiota. J Int Soc Sports Nutr. 2020 May 12;17(1):24. doi: 10.1186/s12970-020-00353-w.

  PMID: 32398103 RESULT

• 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: 28360096 RESULT

• 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: 25021423 RESULT

• Qiu P, Ishimoto T, Fu L, Zhang J, Zhang Z, Liu Y. The Gut Microbiota in Inflammatory Bowel Disease. Front Cell Infect Microbiol. 2022 Feb 22;12:733992. doi: 10.3389/fcimb.2022.733992. eCollection 2022.

  PMID: 35273921 RESULT

• Oligschlaeger Y, Yadati T, Houben T, Condello Olivan CM, Shiri-Sverdlov R. Inflammatory Bowel Disease: A Stressed "Gut/Feeling". Cells. 2019 Jun 30;8(7):659. doi: 10.3390/cells8070659.

  PMID: 31262067 RESULT

• Estaki M, Pither J, Baumeister P, Little JP, Gill SK, Ghosh S, Ahmadi-Vand Z, Marsden KR, Gibson DL. Cardiorespiratory fitness as a predictor of intestinal microbial diversity and distinct metagenomic functions. Microbiome. 2016 Aug 8;4(1):42. doi: 10.1186/s40168-016-0189-7.

  PMID: 27502158 RESULT

• Hou K, Wu ZX, Chen XY, Wang JQ, Zhang D, Xiao C, Zhu D, Koya JB, Wei L, Li J, Chen ZS. Microbiota in health and diseases. Signal Transduct Target Ther. 2022 Apr 23;7(1):135. doi: 10.1038/s41392-022-00974-4.

  PMID: 35461318 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Frozen stool suspension

MeSH Terms

Conditions

Motor Activity; Colitis

Condition Hierarchy (Ancestors)

Behavior; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Frédéric DERBRE, PhD

  Laboratory of Movement, Sport and health Sciences (M2S)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric DERBRE, PhD

CONTACT

+33290091580; frederic.derbre@univ-rennes2.fr

Eglantine LE CHEVERT, M.S.

CONTACT

+33688345332; eglantine.le-chevert@univ-rennes2.fr

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: November 28, 2025
• First Posted: December 11, 2025
• Study Start: November 17, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 15, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)