- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06890741
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
Completed
Conditions
Intervention / Treatment
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
Observational
Enrollment (Actual)
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
-
-
Lubuskie
-
Gorzów Wielkopolski, Lubuskie, Poland, 66-400
- Poznan 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
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 |
Intervention / Treatment |
|---|---|
|
elite rowers
|
Participant perforemed 6000m ergometer test.
|
What is the study measuring?
Primary Outcome Measures
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
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.
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)
November 1, 2023
Primary Completion (Actual)
November 10, 2023
Study Completion (Actual)
November 10, 2023
Study Registration Dates
First Submitted
March 17, 2025
First Submitted That Met QC Criteria
March 17, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 27, 2025
Last Update Submitted That Met QC Criteria
March 24, 2025
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID 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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