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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04156113
Other study ID # 18-10.2/56
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 11, 2019
Est. completion date September 7, 2020

Study information

Verified date September 2020
Source Eastern Mediterranean University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to determine the effect of an acute maximal exercise on serum uncoupling protein-1, irisin, interleukin 6 levels, and on blood lipid and lipoprotein concentrations. This study also evaluates the role of uncoupling protein-1-3826 A/G polymorphism on this eventual effect.

Therefore, this study hypothesizes that:

H01: Sedentary people and athletes' serum uncoupling protein 1, irisin, and interleukine 6 levels are different before and after an acute maximal exercise.

H02: Sedentary people and athletes' basal serum uncoupling protein 1 levels are associated with uncoupling protein 1-3826 A/G polymorphism.

H03: Uncoupling protein 1-3826 A/G polymorphism has a modifying role in the effect of maximal exercise on serum uncoupling protein 1 levels.

H04: Sedentary people and athletes' basal serum lipid and lipoprotein levels are associated with uncoupling protein 1-3826 A/G polymorphism.

H05: Uncoupling protein 1-3826 A / G polymorphism has a modifying role in the effect of maximal exercise on serum lipid and lipoprotein levels.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date September 7, 2020
Est. primary completion date September 2, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- Athletes group:

- Must be basketball, or volleyball, or handball players.

- Must be subjects who have been training regularly for at least 3 months.

- Sedentary group:

* Must be subjects who have not been training regularly for at least 3 months.

- For both groups:

- Healthy.

- Non obese (body mass index < 30).

- Aged between 18 and 35 years.

Exclusion Criteria:

- For both groups:

- Being regular consumer of cigarettes, alcohol, drugs and antioxidant substances.

- Being obese (body mass index > 30).

- Having an acute or chronic injury which is limiting physical performance.

- Having a disease (anemia, infection...) detected from the biochemical analysis of the blood samples.

- Being injured or sick during the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Yo-Yo intermittent recovery test (level 1)
The Yo-Yo intermittent recovery test (level 1) will be administered once.

Locations

Country Name City State
Turkey Ege University Faculty of Sport Sciences Izmir

Sponsors (2)

Lead Sponsor Collaborator
Eastern Mediterranean University Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Change from the baseline serum C reactive protein level at 3 minutes post Yo-Yo intermittent recovery test (level 1) Volunteers' postprandial venous blood samples was taken 15 minutes before the Yo-Yo intermittent recovery test (level 1) and 3 minutes post test. C reactive protein analyzes were performed in the laboratory. 15 minutes before and 3 minutes after the Yo-Yo intermittent recovery test (level 1)
Other Change from the baseline serum creatine kinase level at 3 minutes post Yo-Yo intermittent recovery test (level 1) Volunteers' postprandial venous blood samples was taken 15 minutes before the Yo-Yo intermittent recovery test (level 1) and 3 minutes post test. Creatine kinase analyzes were performed in the laboratory. 15 minutes before and 3 minutes after the Yo-Yo intermittent recovery test (level 1)
Other Change from the baseline serum alanine aminotransferase level at 3 minutes post Yo-Yo intermittent recovery test (level 1) Volunteers' postprandial venous blood samples was taken 15 minutes before the Yo-Yo intermittent recovery test (level 1) and 3 minutes post test. Alanine aminotransferase analyzes were performed in the laboratory. 15 minutes before and 3 minutes after the Yo-Yo intermittent recovery test (level 1)
Other Change from the baseline serum aspartate aminotransferase level at 3 minutes post Yo-Yo intermittent recovery test (level 1) Volunteers' postprandial venous blood samples was taken 15 minutes before the Yo-Yo intermittent recovery test (level 1) and 3 minutes post test. Aspartate aminotransferase analyzes were performed from serum samples in the Medical Biochemistry Laboratory of the Ege University Faculty of Medicine. 15 minutes before and 3 minutes after the Yo-Yo intermittent recovery test (level 1)
Other Change from the baseline hemogram test at 3 minutes post Yo-Yo intermittent recovery test (level 1) Volunteers' postprandial venous blood samples was taken 15 minutes before the Yo-Yo intermittent recovery test (level 1) and 3 minutes post test. Hemogram test analyzes were performed in the laboratory. 15 minutes before and 3 minutes after the Yo-Yo intermittent recovery test (level 1)
Other Change from the baseline at serum glucose level at 3 minutes post Yo-Yo intermittent recovery test (level 1) Volunteers' postprandial venous blood samples was taken 15 minutes before the Yo-Yo intermittent recovery test (level 1) and 3 minutes post test. Glucose analyzes were performed in the laboratory. 15 minutes before and 3 minutes after the Yo-Yo intermittent recovery test (level 1)
Other Change from the baseline serum urea level at 3 minutes post Yo-Yo intermittent recovery test (level 1) Volunteers' postprandial venous blood samples was taken 15 minutes before the Yo-Yo intermittent recovery test (level 1) and 3 minutes post test. Urea analyzes were performed in the laboratory. 15 minutes before and 3 minutes after the Yo-Yo intermittent recovery test (level 1)
Other Change from the baseline serum creatinine level at 3 minutes post Yo-Yo intermittent recovery test (level 1) Volunteers' postprandial venous blood samples was taken 15 minutes before the Yo-Yo intermittent recovery test (level 1) and 3 minutes post test. Creatinine analyzes were performed in the laboratory. 15 minutes before and 3 minutes after the Yo-Yo intermittent recovery test (level 1)
Other Change from the baseline serum total cholesterol level at 3 minutes post Yo-Yo intermittent recovery test (level 1) Volunteers' postprandial venous blood samples was taken 15 minutes before the Yo-Yo intermittent recovery test (level 1) and 3 minutes post test. Total cholesterol analyzes were performed in the laboratory. 15 minutes before and 3 minutes after the Yo-Yo intermittent recovery test (level 1)
Other Change from the baseline serum low density lipoprotein level at 3 minutes post Yo-Yo intermittent recovery test (level 1) Volunteers' postprandial venous blood samples was taken 15 minutes before the Yo-Yo intermittent recovery test (level 1) and 3 minutes post test. Low density lipoprotein analyzes were performed in the laboratory. 15 minutes before and 3 minutes after the Yo-Yo intermittent recovery test (level 1)
Other Change from the baseline serum high density lipoprotein level at 3 minutes post Yo-Yo intermittent recovery test (level 1) Volunteers' postprandial venous blood samples was taken 15 minutes before the Yo-Yo intermittent recovery test (level 1) and 3 minutes post test. High density lipoprotein analyzes were performed in the laboratory. 15 minutes before and 3 minutes after the Yo-Yo intermittent recovery test (level 1)
Other Change from the baseline serum triglyceride level at 3 minutes post Yo-Yo intermittent recovery test (level 1) Volunteers' postprandial venous blood samples was taken 15 minutes before the Yo-Yo intermittent recovery test (level 1) and 3 minutes post test. Triglyceride analyzes were performed in the laboratory. 15 minutes before and 3 minutes after the Yo-Yo intermittent recovery test (level 1)
Other Change from the baseline serum total antioxidant level at 3 minutes post Yo-Yo intermittent recovery test (level 1) Volunteers' postprandial venous blood samples was taken 15 minutes before the Yo-Yo intermittent recovery test (level 1) and 3 minutes post test. Total antioxidant analyzes were performed in the laboratory. 15 minutes before and 3 minutes after the Yo-Yo intermittent recovery test (level 1)
Other Change from the baseline serum total oxidant level at 3 minutes post Yo-Yo intermittent recovery test (level 1) Volunteers' postprandial venous blood samples was taken 15 minutes before the Yo-Yo intermittent recovery test (level 1) and 3 minutes post test. Total oxidant analyzes were performed in the laboratory. 15 minutes before and 3 minutes after the Yo-Yo intermittent recovery test (level 1)
Other Change from the baseline heparin plasma thiobarbituric acid reactive substances level at 3 minutes post Yo-Yo intermittent recovery test (level 1) Volunteers' postprandial venous blood samples was taken 15 minutes before the Yo-Yo intermittent recovery test (level 1) and 3 minutes post test. Thiobarbituric acid reactive substances analyzes were performed in the laboratory. 15 minutes before and 3 minutes after the Yo-Yo intermittent recovery test (level 1)
Primary Change from the baseline serum uncoupling protein 1 level at 3 minutes post Yo-Yo intermittent recovery test (level 1) Volunteers' postprandial venous blood samples were taken 15 minutes before the Yo-Yo intermittent recovery test (level 1) and 3 minutes post test. Uncoupling protein 1 analyzes were performed in the laboratory. 15 minutes before and 3 minutes after the Yo-Yo intermittent recovery test (level 1)
Primary Change from the baseline serum irisin level at 3 minutes post Yo-Yo intermittent recovery test (level 1) Volunteers' postprandial venous blood samples was taken 15 minutes before the Yo-Yo intermittent recovery test (level 1) and 3 minutes post test. Irisin analyzes were performed in the laboratory. 15 minutes before and 3 minutes after the Yo-Yo intermittent recovery test (level 1)
Primary Uncoupling protein-1-3826 A/G polymorphism determination Volunteers' postprandial venous blood samples were taken 15 minutes before the Yo-Yo intermittent recovery test (level 1). Polymorphism was determined in the laboratory. 15 minutes before the Yo-Yo intermittent recovery test (level 1)
Secondary Change from the baseline serum interleukin-6 level at 3 minutes post Yo-Yo intermittent recovery test (level 1) Volunteers' postprandial venous blood samples was taken 15 minutes before the Yo-Yo intermittent recovery test (level 1) and 3 minutes post test. Interleukine-6 analyzes were performed in the laboratory. 15 minutes before and 3 minutes after the Yo-Yo intermittent recovery test (level 1)
Secondary Change from the baseline serum nitric oxide level at 3 minutes post Yo-Yo intermittent recovery test (level 1) Volunteers' postprandial venous blood samples was taken 15 minutes before the Yo-Yo intermittent recovery test (level 1) and 3 minutes post test. Nitric oxide analyzes were performed in the laboratory. 15 minutes before and 3 minutes after the Yo-Yo intermittent recovery test (level 1)
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