Effect of a 4-week Post-exercise Sauna Bathing on Targeted Gut Microbiota

NCT ID: NCT05277597

Last Updated: 2022-03-14

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

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-10

Study Completion Date

2021-06-25

Brief Summary

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

Body temperature fluctuations induced by acute exercise bouts may influence the intestinal barrier with related effects on epithelial permeability, immune responses, and release of metabolites produced by the gut microbiota.

Detailed Description

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

Untrained males aged 22±1.5 years were randomly assigned to exercise training (ET) with or without post-exercise sauna treatments (S). Participants in the group ET+S (n=8) exercised 60 minutes, 3 times per week, on a bicycle ergometer followed by a 30-minute dry Finish sauna treatment. The control group (ET, n=7) engaged in the same exercise training program without the sauna treatments. Blood and stool samples were collected before and after the 4-week training program. Blood samples were analysed for the concentration of high-sensitivity C-reactive protein (hsCRP) and complete blood counts. Stool samples were analysed for pH, quantitative and qualitative measures of targeted bacteria and fungi, zonulin, and secretory immunoglobulin A. This study evaluated the effects of post-exercise sauna bathing in young men undergoing endurance training on gut bacteria inflammation and intestinal barrier function. Investigators hypothesized that sauna bathing applied immediately after a physical training session may impact homeostatic control of the gut microbiota and the function of the intestinal barrier.

Conditions

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

Healthy Males

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study used a randomized, parallel group design. The participants were randomly assigned to exercise training (ET) without or with post-exercise sauna treatments (ET+S) by using a permuted blocks of block size 4. design with a computer.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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

The group (ET)

Participants exercised 60 minutes, 3 times per week

Group Type ACTIVE_COMPARATOR

The same exercise training program without the sauna treatments

Intervention Type DIAGNOSTIC_TEST

The control group (ET, n=7) engaged in the same exercise training program without the sauna treatments. Blood and stool samples were collected before and after the 4-week training program.

The group (ET+S )

Participants exercised 60 minutes, 3 times per week, on a bicycle ergometer followed by a 30-minute dry Finish sauna treatment.

Group Type EXPERIMENTAL

The exercise 60 minutes, 3 times per week, on a bicycle ergometer followed by a 30-minute dry Finish sauna treatment.

Intervention Type DIAGNOSTIC_TEST

Participants in the group ET+S (n=8) exercised 60 minutes, 3 times per week, on a bicycle ergometer followed by a 30-minute dry Finish sauna treatment.Blood and stool samples were collected before and after the 4-week training program.

Interventions

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

The exercise 60 minutes, 3 times per week, on a bicycle ergometer followed by a 30-minute dry Finish sauna treatment.

Participants in the group ET+S (n=8) exercised 60 minutes, 3 times per week, on a bicycle ergometer followed by a 30-minute dry Finish sauna treatment.Blood and stool samples were collected before and after the 4-week training program.

Intervention Type DIAGNOSTIC_TEST

The same exercise training program without the sauna treatments

The control group (ET, n=7) engaged in the same exercise training program without the sauna treatments. Blood and stool samples were collected before and after the 4-week training program.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ET+S ET

Eligibility Criteria

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

Inclusion Criteria

* absence of medical contraindications such as epilepsy,addiction to medicines, alcohol and drugs, cancer, blood clotting disorders,
* no infections in the last 4 weeks prior to the study,
* no injuries in the last 4 weeks prior to the study.

Exclusion Criteria

* the intake of antibiotics, steroids, oral antifungal agents (except for topical antifungals), antiparasitic agents, pre- and/or probiotics,
* history of travel to tropical countries during the last 4 weeks before the study,
* history of adverse responses to sauna bathing.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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

David C. Nieman

UNKNOWN

Sponsor Role collaborator

Tomasz Cisoń

UNKNOWN

Sponsor Role collaborator

Joanna Szurkowska

UNKNOWN

Sponsor Role collaborator

Mirosława Gałęcka

UNKNOWN

Sponsor Role collaborator

Dariusz Sitkowski

UNKNOWN

Sponsor Role collaborator

Zbigniew Szyguła

UNKNOWN

Sponsor Role collaborator

Poznan University of Physical Education

OTHER

Sponsor Role lead

Responsible Party

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

Joanna Karolkiewicz

prof. AWF dr hab.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Joanna Karolkiewicz, Prof.

Role: PRINCIPAL_INVESTIGATOR

Poznan University of Physical Education

Locations

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

Tomasz Cisoń

Nowy Sącz, , Poland

Site Status

Countries

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

Poland

References

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

Karolkiewicz J, Nieman DC, Cison T, Szurkowska J, Galecka M, Sitkowski D, Szygula Z. No effects of a 4-week post-exercise sauna bathing on targeted gut microbiota and intestinal barrier function, and hsCRP in healthy men: a pilot randomized controlled trial. BMC Sports Sci Med Rehabil. 2022 Jun 16;14(1):107. doi: 10.1186/s13102-022-00497-z.

Reference Type DERIVED
PMID: 35710395 (View on PubMed)

Other Identifiers

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

PoznanUPhyEd 25.02.2020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Probiotic Sport Study
NCT01474629 COMPLETED NA