NCT05277597

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
Last Updated

March 14, 2022

Status Verified

March 1, 2022

Enrollment Period

1 month

First QC Date

February 28, 2022

Last Update Submit

March 11, 2022

Conditions

Keywords

gut microbiota, exercise, sauna bathing, intestinal barrier

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 )

EXPERIMENTAL

Participants exercised 60 minutes, 3 times per week, on a bicycle ergometer followed by a 30-minute dry Finish sauna treatment.

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

Diagnostic Test: The same exercise training program without the sauna treatments

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.

Also known as: ET+S
The group (ET+S )

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.

Also known as: ET
The group (ET)

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (1)

Tomasz Cisoń

Nowy Sącz, 33-300, Poland

Location

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.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Joanna Karolkiewicz, Prof.

    Poznan University of Physical Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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.
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

Locations