Endothelial DysfunctionNCT06452758
Relative Energy Deficiency in Rowers
An observational study of Endothelial Dysfunction and Mood Disorders, run by Poznan University of Physical Education at 1 site in Poland.
Trial summary
This study aims to learn about relative energy deficiency in male and female rowers at the end of the direct sport preparation phase of the annual training cycle. The main questions: How will energy intake influence leptin, cortisol levels, mood, gut discomfort, and permeability? The observational study involves male… Read more about this study
- Who is it for?
- Ages 18 to 23 years
- Conditions the study is for
- Endothelial Dysfunction, Mood Disorders, Malnutrition, Calorie
- What is being tested?
- 2000 meter ergometer test
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 20 Jun 2024to 30 Jun 2024
- 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
- All sexes
- No healthy volunteers
- Adult
Study population: Male rowers age 18 - 22 years.
Who may be able to join
- Membership in Polish Rowing Team,
- minimum five years of training,
- total training time minimum of 240 minutes,
- filling out a food diary,
- finishing 2000-meter ergometer test.
Who cannot join
- Probiotics within the last three months,
- prebiotics within the last three months
- antibiotic therapy within the last three months,
- dietary regime,
- gastrointestinal diseases.
Trial locations and contacts
1 site in 1 country.
Anna Skarpańska-Stejnborn, Profesor contact
Poland1 site
Poznan University of Physical Education, Faculty of Sport Sciences in Gorzow
Gorzów Wielkopolski, Lubusz Voivodeship, 66-400
Hanna Dziewiecka, Msc, 606880282, hannadziewiecka@gmail.com
About this study
Official title: Relative Energy Deficiency in Females and Males Rowers - Observational Study
This study aims to learn about relative energy deficiency in male and female rowers at the end of the direct sport preparation phase of the annual training cycle. The main questions:
- How will energy intake influence leptin, cortisol levels, mood, gut discomfort, and permeability? The observational study involves male and female rowers from the Polish rowing team.
Participants will perform 2000 meter ergometer test and 6000 ergometer test in annual training cycle. Researchers will compare outcomes from both tests.
- Being tested
- 2000 meter ergometer test
- Keywords
- relative energy deficiency, gut permeability, rowers
- Medical subject headings
- Mood Disorders, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2000 meter ergometer testOther
Rowers will perform 2000m ergometer test. A 2,000-meter trial is a standard test used to assess performance in rowers.
| Study group | Role | What they receive |
|---|---|---|
| male and female rowers | Rowers will perform 2000m ergometer test.A 2,000-m time trial is a standard test used to assess performance in rowers. Receives: Other: 2000 meter ergometer test |
What is being measured
The primary outcome is the main question the study is designed to answer.
-FABP (intestinal fatty acid binding protein)to measure epithelial wall injury
I-FABP concentration measured in blood [ng/ml] using commercially availableenzyme-linked immunosorbent assays
Measured: Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting) up to one hour after getting up, 1 minute after the test, and 3-hour recovery period
Leptin to measure long-term energy balance
Leptin concentration measured in blood [ng/ml] using commercially availableenzyme-linked immunosorbent assays
Measured: Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting) up to one hour after getting up, 1 minute after the test, and 3-hour recovery period
Cortisol to measure stress
Stress hormone 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) up to one hour after getting up, 1 minute after the test, and 3-hour recovery period
sCD14 multifunctional lipopolysaccharide receptor
sCD14 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) up to one hour after getting up, 1 minute after the test, and 3-hour recovery period
Claudin to measure tight junction leakage
Claudin 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) up to one hour after getting up, 1 minute after the test, and 3-hour recovery period
POMS
Profile of Mood States
Measured: day before the test
REST-Q sport
Recovery-Stress questionnaire for Athletes
Measured: day before the test
Secondary outcomes (11)
energy
energy [kcal ]of food intake measured by food diary
Measured: Time Frame: whole day (24hours) before test, in the morning before the test
protein
protein [g ]of food intake measured by food diary
Measured: Time Frame: whole day (24hours) before test, in the morning before the test
fat
fat [g ]of food intake measured by food diary
Measured: Time Frame: whole day (24hours) before test, in the morning before the test
carbohydrate
carbohydrate [g ]of food intake measured by food diary
Measured: Time Frame: whole day (24hours) before test, in the morning before the test
fiber
fiber [g ]of food intake measured by food diary
Measured: Time Frame: whole day (24hours) 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 up to 1 hour after getting up
Body fat
Body fat [%] measured by electronic scale (Tanita BC 418 MA Tanita Corporation, Tokyo, Japan)
Measured: in the morning before the test up to 1 hour after getting up
Total body water
Body water [%] measured by electronic scale (Tanita BC 418 MA Tanita Corporation, Tokyo, Japan)
Measured: in the morning before the test up to 1 hour after getting up
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 up to 1 hour after getting up
Height
[cm] measured by high meter
Measured: in the morning before the test up to 1 hour after getting up
Self reported scale of gastrointestinal symptoms e.g.burping, heartburn, flatulence, abdominal pain, the urge to reiterate, vomiting, diarrhoea, nausea, dizziness, and stitch
10-point scale where 10 was the symptom with the greatest 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 posted11 Jun 2024
- Study start20 Jun 2024 (estimated)
- Primary completion26 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
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
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Skarpańska-Stejnborn, Profesor, Study director, Poznan University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452758
- Sponsor's protocol ID
- REDs2024
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Energy Deficiency in Females and Males Rowers - Observational Study
- ClinicalTrials.gov ID
- NCT06452758
- Acronym / sponsor ID
- REDs2024
- Keywords
- relative energy deficiency, gut permeability, rowers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 20 Jun 2024 (estimated)
- Primary completion
- 26 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 11 Jun 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.
This study aims to learn about relative energy deficiency in male and female rowers at the end of the direct sport preparation phase of the annual training cycle. The main questions:
- How will energy intake influence leptin, cortisol levels, mood, gut discomfort, and permeability? The observational study involves male and female rowers from the Polish rowing team.
Participants will perform 2000 meter ergometer test and 6000 ergometer test in annual training cycle. Researchers will compare outcomes from both tests.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| male and female rowers | – | Other: 2000 meter ergometer testRowers will perform 2000m ergometer test.A 2,000-m time trial is a standard test used to assess performance in rowers. |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Male rowers age 18 - 22 years.
Key inclusion criteria (5 listed)
- Membership in Polish Rowing Team,
- minimum five years of training,
- total training time minimum of 240 minutes,
- filling out a food diary,
- finishing 2000-meter ergometer test.
Key exclusion criteria (5 listed)
- Probiotics within the last three months,
- prebiotics within the last three months
- antibiotic therapy 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 |
|---|---|---|
| 2000 meter ergometer testRowers will perform 2000m ergometer test. A 2,000-meter trial is a standard test used to assess performance in rowers. | Other | male and female rowers |
Primary outcome
-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) up to one hour after getting up, 1 minute after the test, and 3-hour recovery period
I-FABP concentration measured in blood [ng/ml] using commercially availableenzyme-linked immunosorbent assays
Leptin to measure long-term energy balance
Time frame: Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting) up to one hour after getting up, 1 minute after the test, and 3-hour recovery period
Leptin concentration measured in blood [ng/ml] using commercially availableenzyme-linked immunosorbent assays
Cortisol to measure stress
Time frame: Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting) up to one hour after getting up, 1 minute after the test, and 3-hour recovery period
Stress hormone concentration measured in blood [ng/ml] using commercially available enzyme-linked immunosorbent assays
sCD14 multifunctional lipopolysaccharide receptor
Time frame: Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting) up to one hour after getting up, 1 minute after the test, and 3-hour recovery period
sCD14 concentration measured in blood [ug/ml] using commercially available enzyme-linked immunosorbent assays
Claudin 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) up to one hour after getting up, 1 minute after the test, and 3-hour recovery period
Claudin concentration measured in blood [ng/ml] using commercially available enzyme-linked immunosorbent assays
POMS
Time frame: day before the test
Profile of Mood States
REST-Q sport
Time frame: day before the test
Recovery-Stress questionnaire for Athletes
11 secondary outcomes
energy
Time frame: Time Frame: whole day (24hours) before test, in the morning before the test
protein
Time frame: Time Frame: whole day (24hours) before test, in the morning before the test
fat
Time frame: Time Frame: whole day (24hours) before test, in the morning before the test
carbohydrate
Time frame: Time Frame: whole day (24hours) before test, in the morning before the test
fiber
Time frame: Time Frame: whole day (24hours) before test, in the morning before the test
Body mass
Time frame: in the morning before the test up to 1 hour after getting up
Body fat
Time frame: in the morning before the test up to 1 hour after getting up
Total body water
Time frame: in the morning before the test up to 1 hour after getting up
Lean body mass
Time frame: in the morning before the test up to 1 hour after getting up
Height
Time frame: in the morning before the test up to 1 hour after getting up
Self reported scale of gastrointestinal symptoms e.g.burping, heartburn, flatulence, abdominal pain, the urge to reiterate, vomiting, diarrhoea, nausea, dizziness, and stitch
Time frame: up to 1 hours after the test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
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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, Profesor contact
Anna Skarpańska-Stejnborn, Profesor 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 and Mood Disorders, 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 5 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: status not confirmed, as of the sponsor's last update on 13 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanna Dziewiecka, Msc (606880282 ext. 48, hannadziewiecka@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
-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) up to one hour after getting up, 1 minute after the test, and 3-hour recovery period). The study lists 7 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 13 Jun 2024.