Healthy MalesNCT05277597
Effect of a 4-week Post-exercise Sauna Bathing on Targeted Gut Microbiota
A study testing The exercise 60 minutes, 3 times per week, on a bicycle ergometer followed by a 30-minute dry Finish sauna treatment. and The same exercise training program without the sauna treatments in people with Healthy Males, run by Poznan University of Physical Education at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Males
- What is being tested?
- The exercise 60 minutes, 3 times per week, on a bicycle ergometer followed by a 30-minute dry Finish sauna treatment. and The same exercise training program without the sauna treatments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 sitePoland
- Study dates
- 10 Feb 2020to 25 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Males
- Being tested
- The exercise 60 minutes, 3 times per week, on a bicycle ergometer followed by a 30-minute dry Finish sauna treatment., The same exercise training program without the sauna treatments
- Keywords
- gut microbiota, exercise, sauna bathing, intestinal barrier
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The exercise 60 minutes, 3 times per week, on a bicycle ergometer followed by a 30-minute dry Finish sauna treatment.Diagnostic test
Also called ET+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.Blood and stool samples were collected before and after the 4-week training program.
The same exercise training program without the sauna treatmentsDiagnostic test
Also called ET
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.
| Study group | Role | What they receive |
|---|---|---|
| The group (ET+S ) | Experimental | Participants exercised 60 minutes, 3 times per week, on a bicycle ergometer followed by a 30-minute dry Finish sauna treatment. Receives: Diagnostic Test: The exercise 60 minutes, 3 times per week, on a bicycle ergometer followed by a 30-minute dry Finish sauna treatment. |
| The group (ET) | Active comparator | Participants exercised 60 minutes, 3 times per week Receives: Diagnostic Test: The same exercise training program without the sauna treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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
Measured: baseline and immediately after the intervention
Change from the concentrations of sIgA (marker of mucosal immunity), and zonulin (marker of intestinal permeability) in stool at 4 weeks.
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).
Measured: baseline and immediately after the intervention
Change from the concentration of high-sensitivity C-reactive protein (hsCRP) at 4 weeks.
The concentration of hsCRP was measured by immunoenzymatic assay using a commercially available kit (DRG International Inc., Springfield Township, NJ, USA).
Measured: baseline and immediately after the intervention
Secondary outcomes (2)
Change from the white blood cell counts (WBC) and subsets at 4 weeks.
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).
Measured: baseline and immediately after the intervention
Change feom cardio-respiratory measures at 4 weeks.
Peak oxygen uptake (VO2peak) was assessed with MetaMax 3B analyzer (Cortex, Germany) using a graded exercise test (GXT) with a cycloergometer Cyclus2 (Avantronic, Germany).
Measured: baseline and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start10 Feb 2020
- Primary completion20 Mar 2020
- Study completion25 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy MalesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Collaborators
- David C. Nieman, Tomasz Cisoń, Joanna Szurkowska, Mirosława Gałęcka, Dariusz Sitkowski, Zbigniew Szyguła
- Responsible party
- Principal investigator, Joanna Karolkiewicz, Poznan University of Physical Education
- Investigators
- Joanna Karolkiewicz, Prof., Principal investigator, Poznan University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277597
- Sponsor's protocol ID
- PoznanUPhyEd 25.02.2020
- Status last verified
- Mar 2022
- First submitted
- 28 Feb 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35710395
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05277597
- Acronym / sponsor ID
- PoznanUPhyEd 25.02.2020
- Conditions
- Healthy Males
- Keywords
- gut microbiota, exercise, sauna bathing, intestinal barrier
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Collaborators
- David C. Nieman, Tomasz Cisoń, Joanna Szurkowska, Mirosława Gałęcka, Dariusz Sitkowski, Zbigniew Szyguła
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| The group (ET+S ) | Experimental | Diagnostic Test: The exercise 60 minutes, 3 times per week, on a bicycle ergometer followed by a 30-minute dry Finish sauna treatment.Participants exercised 60 minutes, 3 times per week, on a bicycle ergometer followed by a 30-minute dry Finish sauna treatment. |
| The group (ET) | Active comparator | Diagnostic Test: The same exercise training program without the sauna treatmentsParticipants exercised 60 minutes, 3 times per week |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The exercise 60 minutes, 3 times per week, on a bicycle ergometer followed by a 30-minute dry Finish sauna treatment.Also: ET+SParticipants 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. | Diagnostic test | The group (ET+S ) |
| The same exercise training program without the sauna treatmentsAlso: ETThe 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. | Diagnostic test | The group (ET) |
Primary outcome
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
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
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
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).
Change from the concentration of high-sensitivity C-reactive protein (hsCRP) at 4 weeks.
Time frame: baseline and immediately after the intervention
The concentration of hsCRP was measured by immunoenzymatic assay using a commercially available kit (DRG International Inc., Springfield Township, NJ, USA).
2 secondary outcomes
Change from the white blood cell counts (WBC) and subsets at 4 weeks.
Time frame: baseline and immediately after the intervention
Change feom cardio-respiratory measures at 4 weeks.
Time frame: baseline and immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Derived from this study: PubMed 35710395Karolkiewicz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna Karolkiewicz, Prof. principal investigator
Poznan University of Physical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The exercise 60 minutes, 3 times per week, on a bicycle ergometer followed by a 30-minute dry Finish sauna treatment. and The same exercise training program without the sauna treatments in people with Healthy Males, run by Poznan University of Physical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05277597, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.