- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05277597
Effect of a 4-week Post-exercise Sauna Bathing on Targeted Gut Microbiota
March 11, 2022 updated by: Joanna Karolkiewicz, Poznan University of Physical Education
Effect of a 4-week Post-exercise Sauna Bathing on Targeted Gut Microbiota and Intestinal Barrier Function in Healthy Men: a Randomized Controlled Pilot Trial
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.
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Nowy Sącz, Poland, 33-300
- Tomasz Cisoń
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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.
Other Names:
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Active Comparator: The group (ET)
Participants exercised 60 minutes, 3 times per week
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from abundance of Faecalibacterium prausnitzi of the genus Faecalibacterium, Akkermansia muciniphila of the genus Akkermansia, Bifidobacterium spp. of the genus Actinobacteria and Bacteroides spp. of the genus Bacteroidetes at 4 weeks.
Time Frame: baseline and immediately after the intervention
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Bacterial DNA was isolated from stool samples using the QIAamp Fast DNA Stool Mini Kit (QIAGEN, Danish).
The anaerobic bacteria were determined by Real-Time PCR with appropriate primers (ThermoFisher Scientific, USA).The results of quantitative bacterial analysis were converted to the decimal logarithm (Log10).
The entire Real-Time PCR methodology was developed and validated by the Institute of Microecology in Herborn, Germany
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baseline and immediately after the intervention
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Change from the concentrations of sIgA (marker of mucosal immunity), and zonulin (marker of intestinal permeability) in stool at 4 weeks.
Time Frame: baseline and immediately after the intervention
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Secretory immunoglobulin A concentrations in stool samples were determined with the Secretory IgA test (ImmuChrom GmbH, Heppenheim, Germany).
Zonulin concentrations were assessed using the IKD Zonulin ELISA Kit (Immunodiagnostik AG, Bensheim, Germany).
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baseline and immediately after the intervention
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Change from the concentration of high-sensitivity C-reactive protein (hsCRP) at 4 weeks.
Time Frame: baseline and immediately after the intervention
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The concentration of hsCRP was measured by immunoenzymatic assay using a commercially available kit (DRG International Inc., Springfield Township, NJ, USA).
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baseline and immediately after the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from the white blood cell counts (WBC) and subsets at 4 weeks.
Time Frame: baseline and immediately after the intervention
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Blood samples (approx. 2 ml) were taken from the antecubital vein.Complete blood count indices were determined by flow cytometry with a Synergy 2 SIAFRT analyser (Bio Tek, Winooski, VT, USA).
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baseline and immediately after the intervention
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Change feom cardio-respiratory measures at 4 weeks.
Time Frame: baseline and immediately after the intervention
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Peak oxygen uptake (VO2peak) was assessed with MetaMax 3B analyzer (Cortex, Germany) using a graded exercise test (GXT) with a cycloergometer Cyclus2 (Avantronic, Germany).
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baseline and immediately after the intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Joanna Karolkiewicz, Prof., Poznan University of Physical Education
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 10, 2020
Primary Completion (Actual)
March 20, 2020
Study Completion (Actual)
June 25, 2021
Study Registration Dates
First Submitted
February 28, 2022
First Submitted That Met QC Criteria
March 11, 2022
First Posted (Actual)
March 14, 2022
Study Record Updates
Last Update Posted (Actual)
March 14, 2022
Last Update Submitted That Met QC Criteria
March 11, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- PoznanUPhyEd 25.02.2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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