Exploring the Relationship Between the Gut Microbiome, Physical Fitness Levels and Metabolic Responses to Exercise

NCT ID: NCT05220657

Last Updated: 2023-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-20

Study Completion Date

2022-11-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Gut microbiota are all microorganisms including bacteria, archaea and microscopic eukaryotes that live in the digestive tracts of humans or mammals. All these microorganisms live in homeostasis in the gastrointestinal tract and provide a variety of benefits to the host immune system and energy metabolism in a state called eubiosis. On contrary, a state of dysbiosis occurs when the diversity of commensal bacteria is reduced especially in some chronic diseases including obesity, cancer or gastrointestinal diseases. During the last decade, substantial studies highlighted that a link exists between gut microbiota composition and sport performance. Research team especially identified a direct link between gut microbiota and skeletal muscle, a key organ in sport performance (Nay et al. 2019). Using rodent models, They observed that 1) the endurance performance was reduced in mice for which the gut microbiome had been experimentally destructed (Nay et al. 2019), and 2) the reduction of endurance performance was due to lower muscle glycogen levels, a key energy substrate for muscle endurance.

Complementary researches have been conducted in humans to characterize the impact of physical activity on gut microbiota composition and function. A study conducted in large American cohort of 1500 individuals have thus highlighted that the gut microbiota diversity was much more important in individuals performing regular physical activity (3-5 times/week or more) compared to physically inactive people. The few studies conducted in top-level athletes are in accordance with these results. Indeed, it has been demonstrated that international Irish rugby players exhibited a clear higher microbial diversity than inactive and sedentary populations associated to higher production of short-chain fatty acids (SCFA), some key energy substrates produced by commensal bacteria (Clarke et al. 2014; Barton et al. 2018). Conversely, when people are completely physically deconditioned such as astronauts under microgravity or bedridden patients, a clear modification of gut microbiota composition occurs in the gastrointestinal tract (Voorhies and al. 2019). Such differences between top-level athletes, inactive or extremely inactive individuals cannot be only explained to lifestyle, especially diet. Indeed, longitudinal studies have clearly showed that a several weeks training period can increase the gut microbial diversity in humans suggesting an increased capacity of gut microbiota to extract energy from food, especially from dietary fibers (Allen et al. 2018). All together, these data support that the gut microbiota could adapt to the energy needs of the body, really higher in top-level athletes or considerably lower in extremely inactive individuals (e.g. astronauts or bedridden patients). These data also suggest that gut microbiota could punctually inform of the body's metabolic state of an individual.

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.

For this purpose, we will assess the metabolic responses to exercise from different athletic populations (i.e. elite cyclists and soccer players) and non-active of moderately active populations. All the volunteers (n=50) will perform 3 visits in the M2S lab: 1) an inclusion visit including anthropometric measures, dietary and physical activity surveys, and after which the volunteer will leave the lab with a Nahibu kit allowing to send us a fecal sample in the next 7 days, 2) a second visit to perform the incremental cycling test, 3) a last visit to perform metabolic measures in fasted condition in basal and during submaximal exercises. The metabolic parameters measured during these tests (e.g. VO2max, power in aerobic and anaerobic thresholds, maximal carbohydrates and lipids oxidation) will be then related to the metagenomic shotgun data obtained in fecal samples.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Elite Cyclists Elite Soccer Players Sedentary Behavior

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low active subjects

No intervention

Maximal incremental exercise test

Intervention Type DIAGNOSTIC_TEST

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

Submaximal exercise test

Intervention Type DIAGNOSTIC_TEST

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

Moderately active subjects

No intervention

Maximal incremental exercise test

Intervention Type DIAGNOSTIC_TEST

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

Submaximal exercise test

Intervention Type DIAGNOSTIC_TEST

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

Elite soccer players

No intervention

Maximal incremental exercise test

Intervention Type DIAGNOSTIC_TEST

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

Submaximal exercise test

Intervention Type DIAGNOSTIC_TEST

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

Elite cyclists

No intervention

Maximal incremental exercise test

Intervention Type DIAGNOSTIC_TEST

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

Submaximal exercise test

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Maximal incremental exercise test

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

Intervention Type DIAGNOSTIC_TEST

Submaximal exercise test

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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)
* Simultaneous participation in another research involving the human person or having recently participated in another research for which the exclusion period has not been completed.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nahibu

UNKNOWN

Sponsor Role collaborator

University of Rennes 2

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Frédéric Derbré

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Frédéric DERBRÉ, PhD

Role: PRINCIPAL_INVESTIGATOR

Laboratory of Movement, Sport and health Sciences (M2S)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Bruz, Brittany Region, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 31039010 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25021423 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28360096 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31289321 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29166320 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-A02496-35

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.