- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06452758
Relative Energy Deficiency in Rowers
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hanna Dziewiecka, Msc
- Phone Number: 48 606880282
- Email: hannadziewiecka@gmail.com
Study Contact Backup
- Name: Anna Skarpańska-Stejnborn, Profesor
Study Locations
-
-
Lubuskie
-
Gorzów Wielkopolski, Lubuskie, Poland, 66-400
- Poznan University of Physical Education, Faculty of Sport Sciences in Gorzow
-
Contact:
- Hanna Dziewiecka, Msc
- Phone Number: 606880282
- Email: hannadziewiecka@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Probiotics within the last three months,
- prebiotics within the last three months
- antibiotic therapy within the last three months,
- dietary regime,
- gastrointestinal diseases.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
Rowers will perform 2000m ergometer test.
A 2,000-meter trial is a standard test used to assess performance in rowers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
-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
|
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
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
|
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
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
|
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
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
|
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
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
|
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
Time Frame: day before the test
|
Profile of Mood States
|
day before the test
|
|
REST-Q sport
Time Frame: day before the test
|
Recovery-Stress questionnaire for Athletes
|
day before the test
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
energy
Time Frame: Time Frame: whole day (24hours) before test, in the morning before the test
|
energy [kcal ]of food intake measured by food diary
|
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
|
protein [g ]of food intake measured by food diary
|
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
|
fat [g ]of food intake measured by food diary
|
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
|
carbohydrate [g ]of food intake measured by food diary
|
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
|
fiber [g ]of food intake measured by food diary
|
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 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 up to 1 hour after getting up
|
|
Body fat
Time Frame: in the morning before the test up to 1 hour after getting up
|
Body fat [%] measured by electronic scale (Tanita BC 418 MA Tanita Corporation, Tokyo, Japan)
|
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
|
Body water [%] measured by electronic scale (Tanita BC 418 MA Tanita Corporation, Tokyo, Japan)
|
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
|
Lean body mass [kg] measured by electronic scale (Tanita BC 418 MA Tanita Corporation, Tokyo, Japan)
|
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
|
[cm] measured by high meter
|
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
|
10-point scale where 10 was the symptom with the greatest severity
|
up to 1 hours after the test
|
Collaborators and Investigators
Investigators
- Study Director: Anna Skarpańska-Stejnborn, Profesor, Poznan University of Physical Education
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REDs2024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Mood Disorders
-
Joliet Center for Clinical ResearchAbbottCompleted
-
VA Office of Research and DevelopmentCompleted
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)Completed
-
University of Colorado, DenverCompletedMood Disorders | Irritable MoodUnited States
-
Hanyang UniversityDSM-Firmenich AGActive, not recruiting
-
National Institute of Mental Health (NIMH)Completed
-
Baskent UniversityZİYAFET UĞURLUCompletedDisaster; Personality | Disorder, MoodTurkey
-
Fayoum University HospitalCompletedKetamine-Induced Mood DisorderEgypt
-
Shanghai Mental Health CenterActive, not recruitingMood Disorders in Children and AdolescentsChina
-
Mayo ClinicCompletedMood Disorders in Children and AdolescentsUnited States
Clinical Trials on 2000 meter ergometer test
-
Poznan University of Physical EducationCompleted
-
Poznan University of Physical EducationCompleted
-
Poznan University of Physical EducationNot yet recruitingHealthy Adult Participants
-
Poznan University of Physical EducationCompleted
-
Poznan University of Physical EducationCompletedEndothelial DysfunctionPoland
-
Istanbul UniversityCompletedMorbid ObesityTurkey
-
Marmara UniversityCompleted
-
University of AmericasEnrolling by invitationObesity | Frailty | Sarcopenia | Sarcopenic Obesity | Gait SpeedChile
-
Hacettepe UniversityCompleted
-
Poznan University of Physical EducationCompletedExhaustion - PhysiologicalPoland