- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06895616
Effect of Baseline Cortisol Level on Lipid Peroxidation Products in Young Female Swimmers
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Poznań, Poland, 61-871
- Poznań University of Physical Education
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- antibiotic therapy,
- supplementation, use of any drugs or oral hormonal contraceptives
- health problems within the last months
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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Concentration of 4-Hydroxynonenal (4-HNE) [pg/ml].
ELISA method by the test manufacturer's instructions
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At rest (before the test), directly after the test, and after a 3-hour recovery period.
|
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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.
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Concentration of 8-isoprostane [ng/mL].
ELISA method by the test manufacturer's instructions
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At rest (before the test), directly after the test, and after a 3-hour recovery period.
|
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Changes from baseline in Cortysol level.
Time Frame: At rest (before the test), directly after the test, and after a 3-hour recovery period.
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Concentration of cortysol [ng/mL].
ELISA method by the test manufacturer's instructions
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At rest (before the test), directly after the test, and after a 3-hour recovery period.
|
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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.
|
At rest (before the test), directly after the test, and after a 3-hour recovery period.
|
|
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 [%].
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At rest (before the test), directly after the test, and after a 3-hour recovery period.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Antropometric characteristic - height
Time Frame: Day 1 after overall fast
|
Prior to the exercise test, the investigator measured the anthropometric parameters, including height (Seca 213 Hamburg, Deutschland) [cm]
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Day 1 after overall fast
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Antropometric characteristic - weight
Time Frame: Day 1 after overall fast
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Prior to the exercise test, the investigator measured the anthropometric parameters, including weight (Tanita BC 418 MA, Tanita Corporation, Tokyo, Japan) [kg]
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Day 1 after overall fast
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Food record - energy
Time Frame: Day before the Day 1, in the morning at Day 1
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Participants prepared a food record.
The results were calculated using the dietetykpro program: energy [kcal]
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Day before the Day 1, in the morning at Day 1
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Food record - protein
Time Frame: Day before the Day 1, in the morning at Day 1
|
Participants prepared a food record.
The results were calculated using the dietetykpro program: protein [kcal]
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Day before the Day 1, in the morning at Day 1
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Food record - carobhydrates
Time Frame: Day before the Day 1, in the morning at Day 1
|
Participants prepared a food record.The results were calculated using the dietetykpro program: carobhydrates [kcal]
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Day before the Day 1, in the morning at Day 1
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Food record - fiber
Time Frame: Day before the Day 1, in the morning at Day 1
|
Participants prepared a food record.
The results were calculated using the dietetykpro program: fiber [kcal]
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Day before the Day 1, in the morning at Day 1
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Food record - fat
Time Frame: Day before the Day 1, in the morning at Day 1
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Participants prepared a food record.
The results were calculated using the dietetykpro program: fat [kcal]
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Day before the Day 1, in the morning at Day 1
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SWIMMER- 2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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