Healthy Males Clinical Trial
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
| Verified date | March 2022 |
| Source | Poznan University of Physical Education |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 15 |
| Est. completion date | June 25, 2021 |
| Est. primary completion date | March 20, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 25 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Poland | Tomasz Cison | Nowy Sacz |
| Lead Sponsor | Collaborator |
|---|---|
| Poznan University of Physical Education | Dariusz Sitkowski, David C. Nieman, Joanna Szurkowska, Miroslawa Galecka, Tomasz Cison, Zbigniew Szygula |
Poland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | 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). | baseline and immediately after the intervention | |
| Secondary | 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). | baseline and immediately after the intervention |
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