- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04156113
Effect of an Exercise on Serum Uncoupling Protein-1 Level and the Role of Uncoupling Protein-1-3826 A/G Polymorphism
The Effect of an Acute Maximal Exercise on Serum Uncoupling Protein-1 Level and the Role of Uncoupling Protein-1-3826 A/G Polymorphism
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Izmir, Turkey
- Ege University Faculty of Sport Sciences
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Athletes Group
The athletes group will be composed of healthy, non obese (body mass index < 30), male basketball, volleyball and handball players aged between 18 and 35 years who have been training regularly for at least 3 months. Participants must not be regular consumer of cigarettes, alcohol, drugs and antioxidant substances. Intervention: Yo-Yo intermittent recovery test (level 1) is administered. |
The Yo-Yo intermittent recovery test (level 1) will be administered once.
|
Experimental: Sedentary Group
The sedentary group will be composed of healthy, non obese (body mass index < 30), male aged between 18 and 35 years who have not been training regularly for at least 3 months. Participants must not be regular consumer of cigarettes, alcohol, drugs and antioxidant substances. Intervention: Yo-Yo intermittent recovery test (level 1) is administered. |
The Yo-Yo intermittent recovery test (level 1) will be administered once.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from the baseline serum uncoupling protein 1 level at 3 minutes post Yo-Yo intermittent recovery test (level 1)
Time Frame: 15 minutes before and 3 minutes after the 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)
|
Change from the baseline serum irisin level at 3 minutes post Yo-Yo intermittent recovery test (level 1)
Time Frame: 15 minutes before and 3 minutes after the 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)
|
Uncoupling protein-1-3826 A/G polymorphism determination
Time Frame: 15 minutes before the 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).
Polymorphism was determined in the laboratory.
|
15 minutes before the Yo-Yo intermittent recovery test (level 1)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from the baseline serum interleukin-6 level at 3 minutes post Yo-Yo intermittent recovery test (level 1)
Time Frame: 15 minutes before and 3 minutes after the 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)
|
Change from the baseline serum nitric oxide level at 3 minutes post Yo-Yo intermittent recovery test (level 1)
Time Frame: 15 minutes before and 3 minutes after the 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)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from the baseline serum C reactive protein level at 3 minutes post Yo-Yo intermittent recovery test (level 1)
Time Frame: 15 minutes before and 3 minutes after the 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)
|
Change from the baseline serum creatine kinase level at 3 minutes post Yo-Yo intermittent recovery test (level 1)
Time Frame: 15 minutes before and 3 minutes after the 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)
|
Change from the baseline serum alanine aminotransferase level at 3 minutes post Yo-Yo intermittent recovery test (level 1)
Time Frame: 15 minutes before and 3 minutes after the 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)
|
Change from the baseline serum aspartate aminotransferase level at 3 minutes post Yo-Yo intermittent recovery test (level 1)
Time Frame: 15 minutes before and 3 minutes after the 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)
|
Change from the baseline hemogram test at 3 minutes post Yo-Yo intermittent recovery test (level 1)
Time Frame: 15 minutes before and 3 minutes after the 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)
|
Change from the baseline at serum glucose level at 3 minutes post Yo-Yo intermittent recovery test (level 1)
Time Frame: 15 minutes before and 3 minutes after the 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)
|
Change from the baseline serum urea level at 3 minutes post Yo-Yo intermittent recovery test (level 1)
Time Frame: 15 minutes before and 3 minutes after the 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)
|
Change from the baseline serum creatinine level at 3 minutes post Yo-Yo intermittent recovery test (level 1)
Time Frame: 15 minutes before and 3 minutes after the 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)
|
Change from the baseline serum total cholesterol level at 3 minutes post Yo-Yo intermittent recovery test (level 1)
Time Frame: 15 minutes before and 3 minutes after the 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)
|
Change from the baseline serum low density lipoprotein level at 3 minutes post Yo-Yo intermittent recovery test (level 1)
Time Frame: 15 minutes before and 3 minutes after the 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)
|
Change from the baseline serum high density lipoprotein level at 3 minutes post Yo-Yo intermittent recovery test (level 1)
Time Frame: 15 minutes before and 3 minutes after the 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)
|
Change from the baseline serum triglyceride level at 3 minutes post Yo-Yo intermittent recovery test (level 1)
Time Frame: 15 minutes before and 3 minutes after the 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)
|
Change from the baseline serum total antioxidant level at 3 minutes post Yo-Yo intermittent recovery test (level 1)
Time Frame: 15 minutes before and 3 minutes after the 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)
|
Change from the baseline serum total oxidant level at 3 minutes post Yo-Yo intermittent recovery test (level 1)
Time Frame: 15 minutes before and 3 minutes after the 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)
|
Change from the baseline heparin plasma thiobarbituric acid reactive substances level at 3 minutes post Yo-Yo intermittent recovery test (level 1)
Time Frame: 15 minutes before and 3 minutes after the 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)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Faruk Turgay, Assoc. Prof, Ege University, Faculty of Sports Science
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 18-10.2/56
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
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