Effect of a 4-week Post-exercise Sauna Bathing on Targeted Gut Microbiota
1 other identifier
interventional
15
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2021
CompletedFirst Submitted
Initial submission to the registry
February 28, 2022
CompletedFirst Posted
Study publicly available on registry
March 14, 2022
CompletedMarch 14, 2022
March 1, 2022
1 month
February 28, 2022
March 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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).
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).
baseline and immediately after the intervention
Secondary Outcomes (2)
Change from the white blood cell counts (WBC) and subsets at 4 weeks.
baseline and immediately after the intervention
Change feom cardio-respiratory measures at 4 weeks.
baseline and immediately after the intervention
Study Arms (2)
The group (ET+S )
EXPERIMENTALParticipants exercised 60 minutes, 3 times per week, on a bicycle ergometer followed by a 30-minute dry Finish sauna treatment.
The group (ET)
ACTIVE COMPARATORParticipants exercised 60 minutes, 3 times per week
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Poznan University of Physical Educationlead
- David C. Niemancollaborator
- Tomasz Cisońcollaborator
- Joanna Szurkowskacollaborator
- Mirosława Gałęckacollaborator
- Dariusz Sitkowskicollaborator
- Zbigniew Szygułacollaborator
Study Sites (1)
Tomasz Cisoń
Nowy Sącz, 33-300, Poland
Related Publications (1)
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.
PMID: 35710395DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joanna Karolkiewicz, Prof.
Poznan University of Physical Education
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- prof. AWF dr hab.
Study Record Dates
First Submitted
February 28, 2022
First Posted
March 14, 2022
Study Start
February 10, 2020
Primary Completion
March 20, 2020
Study Completion
June 25, 2021
Last Updated
March 14, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share