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

March 24, 2025 updated by: Poznan University of Physical Education

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Lubuskie
      • Gorzów Wielkopolski, Lubuskie, Poland, 66-400
        • Poznań University of Physical Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Male rowers age 18 - 24 years.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
elite rowers
Other: exercise test
Participant perforemed 6000m ergometer test.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
I-FABP (intestinal fatty acid binding protein)to measure epithelial wall injury
Time Frame: 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
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
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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.
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.
Claudin 3 to measure tight junction leakage
Time Frame: 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 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
Ferritin to measure iron status
Time Frame: 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.
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
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
body mass
Time Frame: in the morning before the test
Body mass [kg] measured by electronic scale to the nearest 0,05 kg (Tanita BC 418 MA Tanita Corporation, Tokyo, Japan).
in the morning before the test
Body composition - water
Time Frame: in the morning before the test
% of body water measured by electronic scale (Tanita BC 418 MA Tanita Corporation, Tokyo, Japan).
in the morning before the test
Body composition - fat
Time Frame: in the morning before the test
% of body fat measured by electronic scale (Tanita BC 418 MA Tanita Corporation, Tokyo, Japan).
in the morning before the test
energy
Time Frame: day before test, in the morning before the test
energy [kcal ]of food intake measured by 24h dietary recall
day before test, in the morning before the test
protein
Time Frame: day before test, in the morning before the test
protein [g ]of food intake measured by 24h dietary recall
day before test, in the morning before the test
carbohydrate
Time Frame: day before test, in the morning before the test
carbohydrate [g ]of food intake measured by 24h dietary recall
day before test, in the morning before the test
fat
Time Frame: day before test, in the morning before the test
fat [g ]of food intake measured by 24h dietary recall
day before test, in the morning before the test
fiber
Time Frame: day before test, in the morning before the test
fiber [g ]of food intake measured by 24h dietary recall
day before test, in the morning before the test
Lean body mass
Time Frame: in the morning before the test
Lean body mass [kg] measured by electronic scale to the nearest 0,05 kg (Tanita BC 418 MA Tanita Corporation, Tokyo, Japan).
in the morning before the test
Height
Time Frame: in the morning before the test
Prior to the exercise test, we measured the anthropometric parameters, including height (Seca 213 Hamburg, Deutschland) [cm]
in the morning before the test
Gastrointestinal sypthomps self reported scale
Time Frame: up to 1 hours after the test
10 point scale were 10 is a outcome of the worst severity
up to 1 hours after the test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Poznan University of Physical Education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Rowers6000m 2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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