NCT06452758

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

June 20, 2024

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2024

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

6 days

First QC Date

June 5, 2024

Last Update Submit

June 11, 2024

Conditions

Keywords

relative energy deficiencygut permeabilityrowers

Outcome Measures

Primary Outcomes (7)

  • -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

  • 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

  • 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

  • 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

  • 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

  • POMS

    Profile of Mood States

    day before the test

  • REST-Q sport

    Recovery-Stress questionnaire for Athletes

    day before the test

Secondary Outcomes (11)

  • energy

    Time Frame: whole day (24hours) before test, in the morning before the test

  • protein

    Time Frame: whole day (24hours) before test, in the morning before the test

  • fat

    Time Frame: whole day (24hours) before test, in the morning before the test

  • carbohydrate

    Time Frame: whole day (24hours) before test, in the morning before the test

  • fiber

    Time Frame: whole day (24hours) before test, in the morning before the test

  • +6 more secondary outcomes

Study Arms (1)

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.

Other: 2000 meter ergometer test

Interventions

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

male and female rowers

Eligibility Criteria

Age18 Years - 23 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Male rowers age 18 - 22 years.

You may qualify if:

  • 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.

You may not qualify if:

  • Probiotics within the last three months,
  • prebiotics within the last three months
  • antibiotic therapy within the last three months,
  • dietary regime,
  • gastrointestinal diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Physical Education, Faculty of Sport Sciences in Gorzow

Gorzów Wielkopolski, Lubusz Voivodeship, 66-400, Poland

Location

MeSH Terms

Conditions

Mood DisordersMalnutrition

Condition Hierarchy (Ancestors)

Mental DisordersNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Anna Skarpańska-Stejnborn, Profesor

    Poznan University of Physical Education

    STUDY DIRECTOR

Central Study Contacts

Hanna Dziewiecka, Msc

CONTACT

Anna Skarpańska-Stejnborn, Profesor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2024

First Posted

June 11, 2024

Study Start

June 20, 2024

Primary Completion

June 26, 2024

Study Completion

June 30, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Locations