Endothelial DysfunctionRowersNCT06372262
Effect of 2000-meter Rowing Test on Parameters of Intestinal Integrity in Elite Rowers During Competitive Phase
An observational study of Endothelial Dysfunction, run by Poznan University of Physical Education at 1 site in Poland.
Trial summary
The study aimed to check the 2000m ergometer test on markers of gut permeability in the competitive phase of rowers. 18 members of the Polish rowing team took part in the study. Read more about this study
- Who is it for?
- Ages 18 to 23 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- ergometer test
- How many people
- 18 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2022to 30 Jun 2022
- 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 23 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Male rowers age 18 - 22 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 2000-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.
About this study
The study aimed to check the 2000m ergometer test on markers of gut permeability in the competitive phase of rowers. 18 members of the Polish rowing team took part in the study.
Read the detailed description
The phenomenon of epithelial wall leakage has been the subject of investigations within athletic domains such as running and cycling. Nevertheless, there exists an insufficiency of understanding regarding gut permeability in alternative disciplines, such as rowing, particularly following the completion of a standard competitive distance of 2000 meters. Hence, the principal objective of our study was to assess gut permeability after completing a 2000-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 2000-meter ergometer test. Blood samples were taken before the test, after exercise, and after 1-hour of restitution. Parameters, such as I-FABP, LPS, LBP, and zonulin, were determined using appropriate biochemical tests.
- Conditions
- Endothelial Dysfunction
- Being tested
- ergometer test
- Keywords
- endotoxin, gastrointestinal symptoms, gut permeability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ergometer testOther
2000meter rowing ergometer 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
zonulin to measure tight junction leakage
zonulin 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
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.
Secondary outcomes (8)
energy
energy [kcal ]of food intake measured by 24h dietary recall
Measured: day before test
fiber intake
fiber [g] intake day before the test measured by 24h dietary recall
Measured: day before test
protein
protein [g] intake day before the test measured by 24h dietary recall
Measured: day before test
carbohydrate
carbohydrate [g] intake day before the test measured by 24h dietary recall
Measured: day before 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 (Tanita BC 418 MA Tanita Corporation, Tokyo, Japan).
Measured: in the morning before the test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Jun 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Skarpańska-Stejnborn, proffessor, Study director, Poznan University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372262
- Sponsor's protocol ID
- Rowers2022
- Acronym
- Rowers
- Status last verified
- Jun 2022
- First submitted
- 19 Mar 2024
- Last updated
- 17 Apr 2024
- Results posted
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 2000-meter Rowing Test on Parameters of Intestinal Integrity in Elite Rowers During Competitive Phase
- ClinicalTrials.gov ID
- NCT06372262
- Acronym / sponsor ID
- Rowers / Rowers2022
- Conditions
- Endothelial Dysfunction
- Keywords
- endotoxin, gastrointestinal symptoms, gut permeability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 17 Apr 2024 (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 study aimed to check the 2000m ergometer test on markers of gut permeability in the competitive phase of rowers. 18 members of the Polish rowing team took part in the study.
Detailed description
The phenomenon of epithelial wall leakage has been the subject of investigations within athletic domains such as running and cycling. Nevertheless, there exists an insufficiency of understanding regarding gut permeability in alternative disciplines, such as rowing, particularly following the completion of a standard competitive distance of 2000 meters. Hence, the principal objective of our study was to assess gut permeability after completing a 2000-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 2000-meter ergometer test. Blood samples were taken before the test, after exercise, and after 1-hour of restitution. Parameters, such as I-FABP, LPS, LBP, and zonulin, were determined using appropriate biochemical tests.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 23 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Male rowers age 18 - 22 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 2000-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 |
|---|---|---|
| ergometer test2000meter rowing ergometer test | Other | – |
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
zonulin 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
zonulin 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
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)
8 secondary outcomes
energy
Time frame: day before test
fiber intake
Time frame: day before test
protein
Time frame: day before test
carbohydrate
Time frame: day before 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
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 17 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Anna Skarpańska-Stejnborn, proffessor study director
Poznan University of Physical Education
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 Endothelial Dysfunction, 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 17 Apr 2024. 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 5 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 17 Apr 2024.