NCT06890741

Brief Summary

The influence of a 6000m ergometer test on the markers of gut injury, endotoxemia, iron status, stress and inflammation in elite rowers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2023

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

November 1, 2023

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2025

Completed
Last Updated

March 27, 2025

Status Verified

November 1, 2023

Enrollment Period

9 days

First QC Date

March 17, 2025

Last Update Submit

March 24, 2025

Conditions

Keywords

endotoxingut permeabilitygastrointestinal functioniron statusoxidative stress

Outcome Measures

Primary Outcomes (11)

  • 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

  • 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

  • Claudin 3 to measure tight junction leakage

    claudin 3 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

  • 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.

  • Ferritin to measure iron status

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

    Blood samples will be 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.

  • Transferrin to measure iron status

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

    Blood samples will be 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.

  • Hepcidin to measure iron status

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

    Blood samples will be 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.

  • IL-6 (Interleukin-6) to measure inflammation

    IL-6 concentration measured in blood \[ng/l\] using commercially available enzyme-linked immunosorbent assays.

    Blood samples will be 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.

  • HO-1 (Heme Oxygenase 1) to measure oxidative stress

    HO-1 concentration measured in blood \[ng/ml\] using commercially available enzyme-linked immunosorbent assays

    Blood samples will be 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.

  • ACSL4 (Long-chain-fatty-acid-CoA ligase 4 ) to measure oxidative stress

    ACSL4 concentration measured in blood \[pg/ml\] using commercially available enzyme-linked immunosorbent assays.

    Blood samples will be 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.

Secondary Outcomes (11)

  • energy

    day before test, in the morning before the test

  • protein

    day before test, in the morning before the test

  • carbohydrate

    day before test, in the morning before the test

  • fat

    day before test, in the morning before the test

  • fiber

    day before test, in the morning before the test

  • +6 more secondary outcomes

Study Arms (1)

elite rowers

Other: exercise test

Interventions

Participant perforemed 6000m ergometer test.

elite rowers

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Male rowers age 18 - 24 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 6000-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

Gorzów Wielkopolski, Lubusz Voivodeship, 66-400, Poland

Location

MeSH Terms

Interventions

Exercise Test

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Design

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

Study Record Dates

First Submitted

March 17, 2025

First Posted

March 24, 2025

Study Start

November 1, 2023

Primary Completion

November 10, 2023

Study Completion

November 10, 2023

Last Updated

March 27, 2025

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations