NCT06372262

Brief Summary

The study aimed to check the 2000m ergometer test on markers of gut permeability in the competitive phase of rowers. 18 members of the Polish rowing team took part in the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

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

June 1, 2022

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
Last Updated

April 17, 2024

Status Verified

June 1, 2022

Enrollment Period

29 days

First QC Date

March 19, 2024

Last Update Submit

April 12, 2024

Conditions

Keywords

endotoxingastrointestinal symptomsgut permeability

Outcome Measures

Primary Outcomes (5)

  • I-FABP (intestinal fatty acid binding protein)to measure epithelial wall injury

    I-FABP concentration measured in blood \[ng/ml\] using commercially available enzyme-linked immunosorbent assays

    Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 1-hour recovery period

  • zonulin to measure tight junction leakage

    zonulin concentration measured in blood \[ng/ml\] using commercially available enzyme-linked immunosorbent assays

    Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 1-hour recovery period

  • LBP (lipopolysaccharide binding protein) to measure endotoxin

    LBP concentration measured in blood \[ug/ml\] using commercially available enzyme-linked immunosorbent assays

    Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 1-hour recovery period

  • LPS (lipopolysaccharide) to measure endotoxin

    LPS concentration measured in blood \[EU/Ll\] using commercially available enzyme-linked immunosorbent assays

    Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting), one minute after the end of the test, and after a 1-hour recovery period

  • Lactic acid to measure fatigue after the race

    Lactate concentration measured in capillary blood from earlobe \[mmol/L\] using a commercially available kit (Diaglobal, Berlin, Germany)

    Blood samples was taken from earlobe at two-time points: before each stress test (after overnight fasting), one minute after the end of the test.

Secondary Outcomes (8)

  • energy

    day before test

  • fiber intake

    day before test

  • protein

    day before test

  • carbohydrate

    day before test

  • body mass

    in the morning before the test

  • +3 more secondary outcomes

Interventions

2000meter rowing ergometer test

Eligibility Criteria

Age18 Years - 23 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Male rowers age 18 - 22 years.

You may qualify if:

  • minimum five years of training,
  • five training sessions per week minimum,
  • total training time minimum of 240 minutes,
  • membership in the Polish Rowing Team,
  • finishing the 2000-meter ergometer test.

You may not qualify if:

  • antibiotic therapy within the last three months,
  • probiotics and prebiotics within the last three months,
  • dietary regime,
  • gastrointestinal diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Physical Education

Poznan, Poland

Location

Study Officials

  • Anna Skarpańska-Stejnborn, proffessor

    Poznan University of Physical Education

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2024

First Posted

April 17, 2024

Study Start

June 1, 2022

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

April 17, 2024

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations