Clinical trial NCT05277597: Effect of a 4-week Post-exercise Sauna Bathing on Targeted Gut Microbiota
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Males
Keywords: gut microbiota, exercise, sauna bathing, intestinal barrier
Lead sponsor: Poznan University of Physical Education
Sponsor class: OTHER
Collaborators: name: David C. Nieman
name: Tomasz Cisoń
name: Joanna Szurkowska
name: Mirosława Gałęcka
name: Dariusz Sitkowski
name: Zbigniew Szyguła
First posted: 2022-03-14
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: baseline and immediately after the intervention
measure: Change from the concentrations of sIgA (marker of mucosal immunity), and zonulin (marker of intestinal permeability) in stool at 4 weeks.
timeFrame: baseline and immediately after the intervention
measure: Change from the concentration of high-sensitivity C-reactive protein (hsCRP) at 4 weeks.
timeFrame: baseline and immediately after the intervention
Secondary outcomes:
measure: Change from the white blood cell counts (WBC) and subsets at 4 weeks.
timeFrame: baseline and immediately after the intervention
measure: Change feom cardio-respiratory measures at 4 weeks.
timeFrame: baseline and immediately after the intervention
Other outcomes:
Locations:
city: Nowy Sącz
country: Poland
facility: Tomasz Cisoń
Study officials:
affiliation: Poznan University of Physical Education
name: Joanna Karolkiewicz, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.