Uncoupling Protein-1NCT04156113
Effect of an Exercise on Serum Uncoupling Protein-1 Level and the Role of Uncoupling Protein-1-3826 A/G Polymorphism
A study testing Yo-Yo intermittent recovery test (level 1) in people with Uncoupling Protein-1 and Polymorphism, Restriction Fragment Length, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Uncoupling Protein-1, Polymorphism, Restriction Fragment Length, Irisin
- What is being tested?
- Yo-Yo intermittent recovery test (level 1)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Nov 2019to 7 Sep 2020
- Phase
- Interventional
- 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
Show all 9Show fewer
- Healthy.
- Non obese (body mass index < 30).
- Aged between 18 and 35 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Sport Sciences
Izmir
About this study
Official title: 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:
Read more
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.
- Being tested
- Yo-Yo intermittent recovery test (level 1)
- Keywords
- Beige fat cell, Fat tissue, Athletes, Sedentary people, Irisin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yo-Yo intermittent recovery test (level 1)Other
The Yo-Yo intermittent recovery test (level 1) will be administered once.
| Study group | Role | What they receive |
|---|---|---|
| Athletes Group | Experimental | 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. Receives: Other: Yo-Yo intermittent recovery test (level 1) |
| Sedentary Group | Experimental | 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. Receives: Other: Yo-Yo intermittent recovery test (level 1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 15 minutes before and 3 minutes after the Yo-Yo intermittent recovery test (level 1)
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.
Measured: 15 minutes before the Yo-Yo intermittent recovery test (level 1)
Secondary outcomes (2)
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.
Measured: 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)
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.
Measured: 15 minutes before and 3 minutes after the Yo-Yo intermittent recovery test (level 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start11 Nov 2019
- Primary completion2 Sep 2020
- Study completion7 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncoupling Protein-1Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University
- Responsible party
- Principal investigator, Jeffry Roy Chauchat, Eastern Mediterranean University
- Investigators
- Faruk Turgay, Assoc. Prof, Study chair, Ege University, Faculty of Sports Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156113
- Sponsor's protocol ID
- 18-10.2/56
- Status last verified
- Sep 2020
- First submitted
- 4 Nov 2019
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Acute Maximal Exercise on Serum Uncoupling Protein-1 Level and the Role of Uncoupling Protein-1-3826 A/G Polymorphism
- ClinicalTrials.gov ID
- NCT04156113
- Acronym / sponsor ID
- 18-10.2/56
- Keywords
- Beige fat cell, Fat tissue, Athletes, Sedentary people, Irisin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Collaborators
- Ege University
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 2 Sep 2020 (actual)
- Study completion
- 7 Sep 2020 (actual)
- First posted
- 7 Nov 2019 (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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Athletes Group | Experimental | Other: Yo-Yo intermittent recovery test (level 1)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. |
| Sedentary Group | Experimental | Other: Yo-Yo intermittent recovery test (level 1)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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Athletes group:
- Sedentary group:
- For both groups:
Key exclusion criteria (6 listed)
- For both groups:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yo-Yo intermittent recovery test (level 1)The Yo-Yo intermittent recovery test (level 1) will be administered once. | Other | Athletes Group, Sedentary Group |
Primary outcome
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.
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.
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.
2 secondary outcomes
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)
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)
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 9 Sep 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Uncoupling Protein-1
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
Active, not recruiting
Winter-Swimming and Brown Adipose Tissue Activity in Middel-aged Obese Subjects (WinterBAT).
Adipose Tissue, Brown, Brown Adipose Tissue
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.
Faruk Turgay, Assoc. Prof study chair
Ege University, Faculty of Sports Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yo-Yo intermittent recovery test (level 1) in people with Uncoupling Protein-1 and Polymorphism, Restriction Fragment Length, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).
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 9 inclusion and 6 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 9 Sep 2020. 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 Turkey (Türkiye). 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?
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)). The study lists 3 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 9 Sep 2020.