NCT06895616

Brief Summary

Research group: twenty-four and homogeneous female swimmers, who train swimming intensively and attend the Sports Championship School Complex. In this cohort, baseline serum cortisol levels were considered, and the athletes were divided into two groups: 1) Serum cortisol \<230 (normal): n=14 2) Serum cortisol \>230 ng/ml (high): n=10 In this study, the athletes were subjected to intensive swimming tests in breaststroke crawl (800m + 200m + 50m) with 15 minutes of active rest between test sections in the water. Blood samples took from the cubital vein at three time points: before stress test (pre-exercise), one minute after the end of the test (post-exercise), and after a 3-hour recovery period (3h recovery). Measurements morphology, 4-Hydroxynonenal (4-HNE), 8-isoprostane, cortysol levels were determined using ELISA kits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

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

Study Start

First participant enrolled

March 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

10 months

First QC Date

March 19, 2025

Last Update Submit

March 19, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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 3-hour recovery period.

  • Changes from baseline in 8-isoprostane level.

    Concentration of 8-isoprostane \[ng/mL\]. ELISA method by the test manufacturer's instructions

    At rest (before the test), directly after the test, and after a 3-hour recovery period.

  • Changes from baseline in Cortysol level.

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

    At rest (before the test), directly after the test, and after a 3-hour recovery period.

  • a manual blood smear

    was made by placing a drop of blood on a slide and then spreading it with a uniform motion. After drying, it was colored by the May Grunwald-Giemsa method according to the procedure. The stained and fixed smear after drying was viewed under a microscope for quantitative and qualitative assessment.

    At rest (before the test), directly after the test, and after a 3-hour recovery period.

  • complete blood count

    erythrocytes: RBC \[10\^6/mL\], HGB \[g/dL\], HCT \[%\], MCV \[mm\^3\], MCH \[pg\], MCHC \[g/dL\], RDW \[%\].

    At rest (before the test), directly after the test, and after a 3-hour recovery period.

Secondary Outcomes (7)

  • Antropometric characteristic - height

    Day 1 after overall fast

  • Antropometric characteristic - weight

    Day 1 after overall fast

  • Food record - energy

    Day before the Day 1, in the morning at Day 1

  • Food record - protein

    Day before the Day 1, in the morning at Day 1

  • Food record - carobhydrates

    Day before the Day 1, in the morning at Day 1

  • +2 more secondary outcomes

Eligibility Criteria

Age12 Years - 16 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Swimmers attending the Sports Championship School Complex

You may qualify if:

  • valid medical examination,
  • consent of the legal guardian of the underage athlete to participate in the study,
  • Training experience a minimum of three years
  • Student of a sports championship school team,
  • ompletion of the exercise test in the swimming pool - crawl style intensive test (800 m + 200 m + 50 m) on two test deadline

You may not qualify if:

  • antibiotic therapy,
  • supplementation, use of any drugs or oral hormonal contraceptives
  • health problems within the last months

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

Eppendorf tubes with serum.

Study Design

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

Study Record Dates

First Submitted

March 19, 2025

First Posted

March 26, 2025

Study Start

March 1, 2023

Primary Completion

December 28, 2023

Study Completion

December 28, 2023

Last Updated

March 26, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations