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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