Relative Energy Deficiency in Rowers

Endothelial Dysfunction Clinical Trial

Official title:

Relative Energy Deficiency in Females and Males Rowers - Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06452758
• Other study ID #: REDs2024
• Status: Not yet recruiting
• Start date: June 20, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2024
• Source: Poznan University of Physical Education
• Contact: Hanna Dziewiecka, Msc
• Phone: 606880282
• Email: hannadziewiecka[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: June 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 23 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Malnutrition
• Malnutrition, Calorie
• Mood Disorders

Intervention

Other:
• 2000 meter ergometer test
Rowers will perform 2000m ergometer test. A 2,000-meter trial is a standard test used to assess performance in rowers.

Locations

Country	Name	City	State
Poland	Poznan University of Physical Education, Faculty of Sport Sciences in Gorzow	Gorzów Wielkopolski	Lubuskie

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Physical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	-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	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
Primary	Leptin to measure long-term energy balance	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
Primary	Cortisol to measure stress	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
Primary	sCD14 multifunctional lipopolysaccharide receptor	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
Primary	Claudin to measure tight junction leakage	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
Primary	POMS	Profile of Mood States	day before the test
Primary	REST-Q sport	Recovery-Stress questionnaire for Athletes	day before the test
Secondary	energy	energy [kcal ]of food intake measured by food diary	Time Frame: whole day (24hours) before test, in the morning before the test
Secondary	protein	protein [g ]of food intake measured by food diary	Time Frame: whole day (24hours) before test, in the morning before the test
Secondary	fat	fat [g ]of food intake measured by food diary	Time Frame: whole day (24hours) before test, in the morning before the test
Secondary	carbohydrate	carbohydrate [g ]of food intake measured by food diary	Time Frame: whole day (24hours) before test, in the morning before the test
Secondary	fiber	fiber [g ]of food intake measured by food diary	Time Frame: whole day (24hours) before test, in the morning before the test
Secondary	Body mass	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
Secondary	Body fat	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
Secondary	Total body water	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
Secondary	Lean body mass	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
Secondary	Height	[cm] measured by high meter	in the morning before the test up to 1 hour after getting up
Secondary	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	up to 1 hours after the test