NCT06891820

Brief Summary

This study aims to analyze in detail selected indicators of appetite regulation, metabolism, and iron balance in competitive rowers undergoing intense exercise. The project involves assessing dynamic hormonal and biochemical changes in the athletes' bodies, which will allow a better understanding of the body's adaptive mechanisms to prolonged physical strain. Research group: the research will be conducted in a homogeneous group of professional rowers (N=30), all competitors qualified for the Polish Youth Rowing Team:

  • aged 19 - 24, because the age group must be homogeneous,
  • the size of the group is about thirty people, which in the case of a homogeneous group will enable statistical analyzes to be conducted. Rowing performance test: At the beginning and end of the training camp, participants will perform a test on a rowing ergometer (Concept II, USA). Each subject will have to cover a distance of 2000 m in the shortest possible time, which is the distance starting in rowing competitions. The results of both tests will be considered in the selection for the championship team; therefore, athletes will be well motivated to perform both tests with maximum effort. Blood samples will be taken from the cubital vein at three-time points: before each ergometer test (after overnight fasting), directly after the test, and after a 1-hour recovery period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 24, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

March 29, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2025

Completed
Last Updated

September 11, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

March 3, 2025

Last Update Submit

September 4, 2025

Conditions

Outcome Measures

Primary Outcomes (49)

  • The Blood morphology

    Using MYTHIC18 hematology analyzer (Cormay Diagnostics, Geneva, Switzerland). Qualitative and quantitative evaluation of morphological elements of blood (determination in venous blood).

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in Glycogen level.

    Concentration of glycogen \[ng/mL\]. Immunoenzymatic assay method using a diagnostic ELISA Kit

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline Insulin level.

    Concentration of insulin \[μIU/mL\]. Immunoenzymatic assay method using a diagnostic ELISA Kit

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baselineCreatine kinase activity (CK) level.

    Concetration of CK \[ng/ml\]. Immunoenzymatic assay method using a diagnostic ELISA Kit

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline interleukin-6 (Il-6) level.

    Concentration of Il-6 \[pg/mL\]. Immunoenzymatic assay method using a diagnostic ELISA Kit

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in fibroblast growth factor 21 (FGF-21) level.

    Concentration of FGF-21 \[pg/mL\]. Immunoenzymatic assay method using a diagnostic ELISA Kit

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in lactic acid (LA) level.

    Concetration of LA \[mmol/l\]. Using a portable biochemical photometer Vario Photometer II (Diaglobal, Berlin, Germany) (capillary blood from the ear lobe).

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Gene expression

    Genes studied: LEP, GHRL, AGRP, GOT1 and GPX4. RNA isolation will be performed by the column method on the Direct-zol™ RNA MiniPrep Plus Kits, according to the test manufacturer's instructions. Gene expression analysis from cells isolated from blood will be performed by reverse transcription using TaqMan

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in testosterone level.

    Concentration of testosterone \[ng/mL\]. Immunoenzymatic assay method using a diagnostic ELISA Kit

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in serotonin level.

    Concentration of serotonin \[ng/mL\]. Immunoenzymatic assay method using a diagnostic ELISA Kit

    At rest (before the exercise test), 1 minute after the end of the test, after 1 hour of recovery

  • Changes from baseline in progesterone level.

    Concentration of progesterone \[ng/mL\]. Immunoenzymatic assay method using a diagnostic ELISA Kit

    At rest (before the exercise test), 1 minute after the end of the test, after 1 hour of recovery

  • Changes from baseline in estradiol level.

    Concentration of estradiol \[ng/mL\]. Immunoenzymatic assay method using a diagnostic ELISA Kit

    At rest (before the exercise test), 1 minute after the end of the test, after 1 hour of recovery

  • Changes from baseline in dopamine level.

    Concentration of dopamine \[ng/mL\]. Immunoenzymatic assay method using a diagnostic ELISA Kit

    At rest (before the exercise test), 1 minute after the end of the test, after 1 hour of recovery

  • Baseline Mood Profile of Athletes Before Exercise Test Using POMS Questionnaire.

    The Profile of Mood States (POMS) questionnaire measures mood states and emotional well-being.

    At rest (before the exercise test).

  • Baseline Mental Toughness in Sport measured using the Scale of Mental Toughness in Sport (SMTQ)

    Scale of Mental Toughness in Sport (SMTQ) - to assess an athlete's ability to cope with training loads and stress

    At rest (before the exercise test).

  • Baseline Eating Behavior and Attitudes of Athletes Before Exercise Test Using EDE-Q 6.0 Questionnaire.

    The Eating Disorder Examination Questionnaire (EDE-Q) measures the severity of eating disorder behaviors and attitudes.

    At rest (before the exercise test).

  • Baseline Appetite Assessment of Athletes Before Exercise Test Using Visual Analogue Scale (VAS).

    The Visual Analogue Scale (VAS) measures subjective appetite sensations-linear scale from one to 10 where 10 is the strongest feeling.

    At rest (before the exercise test).

  • Changes from baseline in leptin(LEP) level.

    Satiety regulation marker. Concentration of leptin \[pg/ml\].ELISA method by the test manufacturer's instructions.

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in glucagon-like peptide-1 (GLP-1) level.

    Satiety regulation marker. Concentration of GLP-1 \[pg/ml\]. ELISA method by the test manufacturer's instructions.

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in peptide YY (PYY) level.

    Satiety regulation marker. Concentration of leptin \[pg/ml\]. ELISA method by the test manufacturer's instructions.

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in pancreatic polipeptide (PP) level.

    Satiety regulation marker. Concentration of PP \[pg/ml\]. ELISA method by the test manufacturer's instructions

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in ghrelin (GHRL) level.

    Hunger regulation marker. Concentration of GHRL \[pg/ml\].ELISA method by the test manufacturer's instructions.

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in cholocystokinin (CCK) level.

    Satiety regulation marker. Concentration of CCK \[pg/ml\].ELISA method by the test manufacturer's instructions.

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in Soluble transferrin receptor level.

    Concentration of Soluble transferrin receptor \[μg/ml\]. ELISA method by the test manufacturer's instructions.

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in Ferritin level.

    Concentration of ferritin \[ng/mL\]. ELISA method by the test manufacturer's instructions

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in 4-Hydroxynonenal (4-HNE) level.

    Concentration of 4-Hydroxynonenal (4-HNE) \[pg/ml\]. ELISA method by the test manufacturer's instructions

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in Glutathione Peroxidase 4 (GPX4) level.

    Concentration of Human Glutathione Peroxidase 4 (GPX4) \[ng/mL\]. ELISA method by the test manufacturer's instructions

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in Glutathione level.

    Concentration of Glutathione (GSH) \[μg/mL\]. ELISA method by the test manufacturer's instructions.

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in Heme Oxygenase 1(HO-1) level.

    Concentration of Heme Oxygenase 1 (HO-1) \[ng/mL\]. ELISA method by the test manufacturer's instructions

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in Erythroferrone level.

    Concentration of erythroferrone \[ng/mL\]. ELISA method by the test manufacturer's instructions

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in Lactoferrin level.

    Concentration of lactoferrin \[ng/mL\]. ELISA method by the test manufacturer's instructions

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in Iron (Fe) level.

    The iron level \[µg/dL\] will be determined using the colorimetric method on the SPECTROstar Nano reader.

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in acid-base balance - urea nitrogen (BUN) level.

    Concentration of BUN \[ml/dl\]. Using the portable blood gas, electrolyte, and metabolite analyzer (epoc®) (capillary blood from the ear lobe).

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in acid-base balance - anion gap (AGAP) level.

    Concentration of AGAP \[mmol/l\]. Using the portable blood gas, electrolyte, and metabolite analyzer (epoc®) (capillary blood from the ear lobe).

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in acid-base balance - excess base in extracellular fluid (BE ecf) level.

    Concentration of Be ecf \[mmol/l\]. Using the portable blood gas, electrolyte, and metabolite analyzer (epoc®) (capillary blood from the ear lobe).

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in acid-base balance - sodium (Na) level.

    Concentration of Na \[mmol/l\]. Using the portable blood gas, electrolyte, and metabolite analyzer (epoc®) (capillary blood from the ear lobe).

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in acid-base balance - calcium (Ca) level.

    Concentration of Ca \[mmol/l\]. Using the portable blood gas, electrolyte, and metabolite analyzer (epoc®) (capillary blood from the ear lobe).

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in acid-base balance - potassium (K) level.

    Concentration of K \[mmol/l\]. Using the portable blood gas, electrolyte, and metabolite analyzer (epoc®) (capillary blood from the ear lobe).

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in acid-base balance - chlorine (Cl) level.

    Concentration of Cl \[mmol/l\]. Using the portable blood gas, electrolyte, and metabolite analyzer (epoc®) (capillary blood from the ear lobe).

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in acid-base balance - bicarbonate level (cHCO3).

    Concentration of cHCO3 \[mmol/l\]. Using the portable blood gas, electrolyte, and metabolite analyzer (epoc®) (capillary blood from the ear lobe).

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in acid-base balance - total plasma CO2 (tCO2) level.

    Concentration of tCO2 \[mmol/l\]. Using the portable blood gas, electrolyte, and metabolite analyzer (epoc®) (capillary blood from the ear lobe).

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in acid-base balance - partial pressure of carbon dioxide (pCO2)

    Concentration of pCO2 \[mmol/l\]. Using the portable blood gas, electrolyte, and metabolite analyzer (epoc®) (capillary blood from the ear lobe).

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in acid-base balance - partial pressure of oxygen (pO2)

    Concentration of pO2 \[mmol/l\]. Using the portable blood gas, electrolyte, and metabolite analyzer (epoc®) (capillary blood from the ear lobe).

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in acid-base balance -total blood saturation (cSO2) level.

    Concentration of cSO2 \[mmol/l\]. Using the portable blood gas, electrolyte, and metabolite analyzer (epoc®) (capillary blood from the ear lobe).

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in acid-base balance - urea level.

    Concentration of urea \[mmol/l\]. Using the portable blood gas, electrolyte, and metabolite analyzer (epoc®) (capillary blood from the ear lobe).

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in acid-base balance - crea level.

    Concentration of crea \[mg/dl\]. Using the portable blood gas, electrolyte, and metabolite analyzer (epoc®) (capillary blood from the ear lobe).

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in acid-base balance - hematocrit [hct] level.

    Concentration of hct \[%\]. Using the portable blood gas, electrolyte, and metabolite analyzer (epoc®) (capillary blood from the ear lobe).

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in acid-base balance - hemoglobin [chgb] level.

    Concentration of chgb \[mmol/l\]. Using the portable blood gas, electrolyte, and metabolite analyzer (epoc®) (capillary blood from the ear lobe).

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

  • Changes from baseline in acid-base balance - glukose [glu] level.

    Concentration of glu \[mg/dl\]. Using the portable blood gas, electrolyte, and metabolite analyzer (epoc®) (capillary blood from the ear lobe).

    At rest (before the test), directly after the test, and after a 1-hour recovery period.

Secondary Outcomes (11)

  • Antropometric characteristic - height

    Day 1 after overall fast

  • Antropometric characteristic - weight

    Day 1 after overall fast

  • Antropometric characteristic - LBM

    Day 1 after overall fast

  • Antropometric characteristic - TBW

    Day 1 after overall fast

  • Antropometric characteristic - Water%

    Day 1 after overall fast

  • +6 more secondary outcomes

Study Arms (1)

Physical effort

Rowers will perform an intensive exercise test on a rowing ergometer (Concept II, USA), covering a distance of 2000 meters in the shortest time possible. The test on the rowing ergometer will be performed under the supervision of a physician.

Other: Physical effort

Interventions

The examined athletes will be subjected to an effort on a rowing ergometer, covering a designated distance in the shortest possible time.

Physical effort

Eligibility Criteria

Age19 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The Polish Youth Rowing Team

You may qualify if:

  • consent to participate in the study,
  • regular training regimen,
  • current medical examination,
  • no health contraindications (to be decided by a doctor).

You may not qualify if:

  • Lack of consent for blood draws,
  • injuries,
  • health problems,
  • anti-inflammatory drugs,
  • supportive substances, supplements in the last 3 months before the start of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznań University of Physical Education

Poznan, 61-871, Poland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

1. Polyethylene tubes (4.9 ml) containing dipotassium ethylenediaminetetraacetic acid (EDTAK2) anticoagulant. 2. Polyethylene clotting activator tubes (9 ml)

MeSH Terms

Conditions

InflammationNervous System Diseases

Interventions

Physical Exertion

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Anna Skarpańska-Stejborn, Professor

    Poznań University of Physical Education, Faculty of Sport Sciences in Gorzów Wielkopolski, Poland;

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

March 3, 2025

First Posted

March 24, 2025

Study Start

March 29, 2025

Primary Completion

June 28, 2025

Study Completion

June 29, 2025

Last Updated

September 11, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations