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Endothenial Dysfunction6000mNCT06890741

Inflamation, Gut Leakage, Iron Status After 6000m Ergometer Test in Elite Rowers.

An observational study of Endothenial Dysfunction and Iron Status, run by Poznan University of Physical Education at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?
Ages 18 to 24 yearsHealthy volunteers can take part
What is being tested?
exercise test
How many people
21 participants
Where
1 sitePoland
Study dates
1 Nov 2023to 10 Nov 2023
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 24 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Male rowers age 18 - 24 years.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • Poznan University of Physical Education

    Gorzów Wielkopolski, Lubusz Voivodeship, 66-400

Other trials in Poland

About this study

Official title: Influance of 6000m Ergometer Test on Inflammatory, Permeability Markers and Iron Status.

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

Read the detailed description

The principal objective of our study was to assess gut permeability after completing a 6000-meter rowing test. The study was performed at the beginning of a competitive training phase. Eighteen elite Polish Rowing Team rowers participated in the study after applying the inclusion/exclusion criteria. The participants performed a 6000-meter ergometer test. Blood samples were taken before the test, after exercise, and after 1 hour of restitution. Parameters, such as I-FABP (intestinal fatty acid binding protein), LPS (lipopolysaccharide), LBP (lipopolysaccharide binding protein), claudin3, ferritin, transferrin, hepcidin, IL-6 (Interleukin-6), HO-1 (Heme Oxygenase 1), and ACSL4 (Long-chain-fatty-acid-CoA ligase 4 ) were determined using appropriate biochemical tests.

Being tested
exercise test
Keywords
endotoxin, gut permeability, gastrointestinal function, iron status, oxidative stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • exercise testOther

    Participant perforemed 6000m ergometer test.

Study groups in NCT06890741
Study groupRoleWhat they receive
elite rowersNot described
Receives: Other: exercise test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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

  2. LBP (lipopolysaccharide binding protein) to measure endotoxin

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

    Measured: 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

  3. Claudin 3 to measure tight junction leakage

    claudin 3 concentration measured in blood [ng/ml] using commercially available enzyme-linked immunosorbent assays

    Measured: 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

  4. LPS (lipopolysaccharide) to measure endotoxin

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

    Measured: 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

  5. 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)

    Measured: 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.

  6. Ferritin to measure iron status

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

    Measured: 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.

  7. Transferrin to measure iron status

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

    Measured: 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.

  8. Hepcidin to measure iron status

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

    Measured: 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.

  9. IL-6 (Interleukin-6) to measure inflammation

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

    Measured: 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.

  10. HO-1 (Heme Oxygenase 1) to measure oxidative stress

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

    Measured: 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.

  11. 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.

    Measured: 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)
  1. energy

    energy [kcal ]of food intake measured by 24h dietary recall

    Measured: day before test, in the morning before the test

  2. protein

    protein [g ]of food intake measured by 24h dietary recall

    Measured: day before test, in the morning before the test

  3. carbohydrate

    carbohydrate [g ]of food intake measured by 24h dietary recall

    Measured: day before test, in the morning before the test

  4. fat

    fat [g ]of food intake measured by 24h dietary recall

    Measured: day before test, in the morning before the test

  5. fiber

    fiber [g ]of food intake measured by 24h dietary recall

    Measured: day before test, in the morning before the test

  6. body mass

    Body mass [kg] measured by electronic scale to the nearest 0,05 kg (Tanita BC 418 MA Tanita Corporation, Tokyo, Japan).

    Measured: in the morning before the test

  7. Body composition - water

    % of body water measured by electronic scale (Tanita BC 418 MA Tanita Corporation, Tokyo, Japan).

    Measured: in the morning before the test

  8. Body composition - fat

    % of body fat measured by electronic scale (Tanita BC 418 MA Tanita Corporation, Tokyo, Japan).

    Measured: in the morning before the test

  9. Lean body mass

    Lean body mass [kg] measured by electronic scale to the nearest 0,05 kg (Tanita BC 418 MA Tanita Corporation, Tokyo, Japan).

    Measured: in the morning before the test

  10. Height

    Prior to the exercise test, we measured the anthropometric parameters, including height (Seca 213 Hamburg, Deutschland) [cm]

    Measured: in the morning before the test

  11. Gastrointestinal sypthomps self reported scale

    10 point scale were 10 is a outcome of the worst severity

    Measured: up to 1 hours after the test

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2025
  2. Study start1 Nov 2023
  3. Primary completion10 Nov 2023
  4. Study completion10 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06890741
Sponsor's protocol ID
Rowers6000m 2023
Acronym
6000m
Status last verified
Nov 2023
First submitted
17 Mar 2025
Last updated
27 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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