Stress OxidativeNCT06895616
Effect of Baseline Cortisol Level on Lipid Peroxidation Products in Young Female Swimmers
An observational study of Stress Oxidative, run by Poznan University of Physical Education at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 16 years, women only
- Conditions the study is for
- Stress Oxidative
- How many people
- 24 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2023to 28 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- Women only
- No healthy volunteers
- Child
Study population: Swimmers attending the Sports Championship School Complex
Who may be able to join
- 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
Who cannot join
- antibiotic therapy,
- supplementation, use of any drugs or oral hormonal contraceptives
- health problems within the last months
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The data of 24 trained female from the Sports Championship School Complex. All athletes presented as medically fit, with no underlying health problems. 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 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 1-hour recovery period (3h recovery).
Measurement: All determined parameters were measured with the available equipment in the ZWKF laboratory in Gorzów Wielkopolski and using commercial assay kits. Measurements were performed by the project contractors.
- Polyethylene tubes (2.7ml) containing dipotassium ethylenediaminetetraacetic acid (EDTAK2) anticoagulant were used for the following tests: (a) complete blood count (7 parameters) determined on the MYTHIC 18 hematology analyzer (Orphee Medical, Geneva, Switzerland). Red blood cell indices: RBC (Red Blood Cells), HGB (Hemoglobin), HCT (Hematocrit), MCV (Mean Corpuscular Volume), MCH (Mean Corpuscular Hemoglobin), MCHC (Mean Corpuscular Hemoglobin Concentration), RDW (Red Blood cells Distribution Width). (b) 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.
- Polyethylene clotting activator tubes (9 ml) were centrifuged to separate the morphotic elements from the serum using a centrifuge (3000 rpm for 10 min). The serum was pipetted into several Eppendorf tubes, which then was frozen (temp. -80 °C). All the following biochemical parameters were determined from the extracted serum: (a) using the ELISA method by the test manufacturer's instructions. The designations include the flowing parameters:
4-Hydroxynonenal (4-HNE), 8-isoprostane, cortysol. (3) The lactate (La) concentration was determined from the capillary blood immediately after collection using a commercially available kit (Dr. Lange, Germany).
The athletes' diets were completely analyzed before each exercise test by a nutritionist. Participants, with the help of a dietician who was available during meals on test days, filled out food diaries. The amount of energy, protein, carbohydrates, fats and fiber were then analyzed using a commercially available program.
The experiment was conducted in accordance with the Declaration of Helsinki. The study protocol was approved by the Ethical Committee of the Medical University of Poznan
- Conditions
- Stress Oxidative
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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 [%].
Measured: At rest (before the test), directly after the test, and after a 3-hour recovery period.
Secondary outcomes (7)
Antropometric characteristic - height
Prior to the exercise test, the investigator measured the anthropometric parameters, including height (Seca 213 Hamburg, Deutschland) [cm]
Measured: Day 1 after overall fast
Antropometric characteristic - weight
Prior to the exercise test, the investigator measured the anthropometric parameters, including weight (Tanita BC 418 MA, Tanita Corporation, Tokyo, Japan) [kg]
Measured: Day 1 after overall fast
Food record - energy
Participants prepared a food record. The results were calculated using the dietetykpro program: energy [kcal]
Measured: Day before the Day 1, in the morning at Day 1
Food record - protein
Participants prepared a food record. The results were calculated using the dietetykpro program: protein [kcal]
Measured: Day before the Day 1, in the morning at Day 1
Food record - carobhydrates
Participants prepared a food record.The results were calculated using the dietetykpro program: carobhydrates [kcal]
Measured: Day before the Day 1, in the morning at Day 1
Food record - fiber
Participants prepared a food record. The results were calculated using the dietetykpro program: fiber [kcal]
Measured: Day before the Day 1, in the morning at Day 1
Food record - fat
Participants prepared a food record. The results were calculated using the dietetykpro program: fat [kcal]
Measured: Day before the Day 1, in the morning at Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start1 Mar 2023
- Primary completion28 Dec 2023
- Study completion28 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress OxidativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895616
- Sponsor's protocol ID
- SWIMMER- 2024
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Baseline Cortisol Level on Lipid Peroxidation Products in Young Female Swimmers
- ClinicalTrials.gov ID
- NCT06895616
- Acronym / sponsor ID
- SWIMMER- 2024
- Conditions
- Stress Oxidative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 28 Dec 2023 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The data of 24 trained female from the Sports Championship School Complex. All athletes presented as medically fit, with no underlying health problems. 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 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 1-hour recovery period (3h recovery).
Measurement: All determined parameters were measured with the available equipment in the ZWKF laboratory in Gorzów Wielkopolski and using commercial assay kits. Measurements were performed by the project contractors.
- Polyethylene tubes (2.7ml) containing dipotassium ethylenediaminetetraacetic acid (EDTAK2) anticoagulant were used for the following tests: (a) complete blood count (7 parameters) determined on the MYTHIC 18 hematology analyzer (Orphee Medical, Geneva, Switzerland). Red blood cell indices: RBC (Red Blood Cells), HGB (Hemoglobin), HCT (Hematocrit), MCV (Mean Corpuscular Volume), MCH (Mean Corpuscular Hemoglobin), MCHC (Mean Corpuscular Hemoglobin Concentration), RDW (Red Blood cells Distribution Width). (b) 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.
- Polyethylene clotting activator tubes (9 ml) were centrifuged to separate the morphotic elements from the serum using a centrifuge (3000 rpm for 10 min). The serum was pipetted into several Eppendorf tubes, which then was frozen (temp. -80 °C). All the following biochemical parameters were determined from the extracted serum: (a) using the ELISA method by the test manufacturer's instructions. The designations include the flowing parameters:
4-Hydroxynonenal (4-HNE), 8-isoprostane, cortysol. (3) The lactate (La) concentration was determined from the capillary blood immediately after collection using a commercially available kit (Dr. Lange, Germany).
The athletes' diets were completely analyzed before each exercise test by a nutritionist. Participants, with the help of a dietician who was available during meals on test days, filled out food diaries. The amount of energy, protein, carbohydrates, fats and fiber were then analyzed using a commercially available program.
The experiment was conducted in accordance with the Declaration of Helsinki. The study protocol was approved by the Ethical Committee of the Medical University of Poznan
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 12 to 16 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Swimmers attending the Sports Championship School Complex
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- antibiotic therapy,
- supplementation, use of any drugs or oral hormonal contraceptives
- health problems within the last months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes from baseline in 4-Hydroxynonenal (4-HNE) level.
Time frame: At rest (before the test), directly after the test, and after a 3-hour recovery period.
Concentration of 4-Hydroxynonenal (4-HNE) [pg/ml]. ELISA method by the test manufacturer's instructions
Changes from baseline in 8-isoprostane level.
Time frame: At rest (before the test), directly after the test, and after a 3-hour recovery period.
Concentration of 8-isoprostane [ng/mL]. ELISA method by the test manufacturer's instructions
Changes from baseline in Cortysol level.
Time frame: At rest (before the test), directly after the test, and after a 3-hour recovery period.
Concentration of cortysol [ng/mL]. ELISA method by the test manufacturer's instructions
a manual blood smear
Time frame: At rest (before the test), directly after the test, and after a 3-hour recovery period.
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.
complete blood count
Time frame: At rest (before the test), directly after the test, and after a 3-hour recovery period.
erythrocytes: RBC [10^6/mL], HGB [g/dL], HCT [%], MCV [mm^3], MCH [pg], MCHC [g/dL], RDW [%].
7 secondary outcomes
Antropometric characteristic - height
Time frame: Day 1 after overall fast
Antropometric characteristic - weight
Time frame: Day 1 after overall fast
Food record - energy
Time frame: Day before the Day 1, in the morning at Day 1
Food record - protein
Time frame: Day before the Day 1, in the morning at Day 1
Food record - carobhydrates
Time frame: Day before the Day 1, in the morning at Day 1
Food record - fiber
Time frame: Day before the Day 1, in the morning at Day 1
Food record - fat
Time frame: Day before the Day 1, in the morning at Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Oxidative, run by Poznan University of Physical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in 4-Hydroxynonenal (4-HNE) level. (time frame: At rest (before the test), directly after the test, and after a 3-hour recovery period.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.