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.
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
- Conditions the study is for
- Endothenial Dysfunction, Iron Status, Oxidative Stress
- What is being tested?
- exercise test
- How many people
- 21 participants
- Where
- 1 sitePoland
- Study dates
- 1 Nov 2023to 10 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
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.
- Conditions
- Endothenial Dysfunction, Iron Status, Oxidative Stress
- 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 group | Role | What they receive |
|---|---|---|
| elite rowers | Not described Receives: Other: exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
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
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.
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.
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.
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.
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.
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.
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)
energy
energy [kcal ]of food intake measured by 24h dietary recall
Measured: day before test, in the morning before the test
protein
protein [g ]of food intake measured by 24h dietary recall
Measured: day before test, in the morning before the test
carbohydrate
carbohydrate [g ]of food intake measured by 24h dietary recall
Measured: day before test, in the morning before the test
fat
fat [g ]of food intake measured by 24h dietary recall
Measured: day before test, in the morning before the test
fiber
fiber [g ]of food intake measured by 24h dietary recall
Measured: day before test, in the morning before the test
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
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
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
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
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
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.
- First posted24 Mar 2025
- Study start1 Nov 2023
- Primary completion10 Nov 2023
- Study completion10 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothenial DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influance of 6000m Ergometer Test on Inflammatory, Permeability Markers and Iron Status.
- ClinicalTrials.gov ID
- NCT06890741
- Acronym / sponsor ID
- 6000m / Rowers6000m 2023
- Conditions
- Endothenial Dysfunction, Iron Status, Oxidative Stress
- Keywords
- endotoxin, gut permeability, gastrointestinal function, iron status, oxidative stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The influence of a 6000m ergometer test on the markers of gut injury, endotoxemia, iron status, stress and inflammation in elite rowers.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| elite rowers | – | Other: exercise test |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Male rowers age 18 - 24 years.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- antibiotic therapy within the last three months,
- probiotics and prebiotics within the last three months,
- dietary regime,
- gastrointestinal diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise testParticipant perforemed 6000m ergometer test. | Other | elite rowers |
Primary outcome
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
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
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
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
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)
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
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
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
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.
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
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.
11 secondary outcomes
energy
Time frame: day before test, in the morning before the test
protein
Time frame: day before test, in the morning before the test
carbohydrate
Time frame: day before test, in the morning before the test
fat
Time frame: day before test, in the morning before the test
fiber
Time frame: day before test, in the morning before the test
body mass
Time frame: in the morning before the test
Body composition - water
Time frame: in the morning before the test
Body composition - fat
Time frame: in the morning before the test
Lean body mass
Time frame: in the morning before the test
Height
Time frame: in the morning before the test
Gastrointestinal sypthomps self reported scale
Time frame: up to 1 hours after the test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endothenial Dysfunction and Iron Status, run by Poznan University of Physical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.