Clinical trial NCT06452758: Relative Energy Deficiency in Rowers
Official title: Relative Energy Deficiency in Females and Males Rowers - Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Endothelial Dysfunction
Mood Disorders
Malnutrition, Calorie
Keywords: relative energy deficiency
gut permeability
rowers
Lead sponsor: Poznan University of Physical Education
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male rowers age 18 - 22 years.

Brief 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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: -FABP (intestinal fatty acid binding protein)to measure epithelial wall injury
timeFrame: 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
measure: Leptin to measure long-term energy balance
timeFrame: 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
measure: Cortisol to measure stress
timeFrame: 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
measure: sCD14 multifunctional lipopolysaccharide receptor
timeFrame: 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
measure: Claudin to measure tight junction leakage
timeFrame: 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
measure: POMS
timeFrame: day before the test
measure: REST-Q sport
timeFrame: day before the test
Secondary outcomes:
measure: energy
timeFrame: Time Frame: whole day (24hours) before test, in the morning before the test
measure: protein
timeFrame: Time Frame: whole day (24hours) before test, in the morning before the test
measure: fat
timeFrame: Time Frame: whole day (24hours) before test, in the morning before the test
measure: carbohydrate
timeFrame: Time Frame: whole day (24hours) before test, in the morning before the test
measure: fiber
timeFrame: Time Frame: whole day (24hours) before test, in the morning before the test
measure: Body mass
timeFrame: in the morning before the test up to 1 hour after getting up
measure: Body fat
timeFrame: in the morning before the test up to 1 hour after getting up
measure: Total body water
timeFrame: in the morning before the test up to 1 hour after getting up
measure: Lean body mass
timeFrame: in the morning before the test up to 1 hour after getting up
measure: Height
timeFrame: in the morning before the test up to 1 hour after getting up
measure: Self reported scale of gastrointestinal symptoms e.g.burping, heartburn, flatulence, abdominal pain, the urge to reiterate, vomiting, diarrhoea, nausea, dizziness, and stitch
timeFrame: up to 1 hours after the test
Other outcomes:
Locations:
city: Gorzów Wielkopolski
country: Poland
facility: Poznan University of Physical Education, Faculty of Sport Sciences in Gorzow
state: Lubuskie
Study officials:
affiliation: Poznan University of Physical Education
name: Anna Skarpańska-Stejnborn, Profesor
role: STUDY_DIRECTOR
References: