NCT04156113

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

November 11, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

10 months

First QC Date

November 4, 2019

Last Update Submit

September 7, 2020

Conditions

Keywords

Beige fat cellFat tissueAthletesSedentary peopleIrisin

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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 Outcomes (2)

  • Change from the baseline serum interleukin-6 level at 3 minutes post Yo-Yo intermittent recovery test (level 1)

    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)

    15 minutes before and 3 minutes after the Yo-Yo intermittent recovery test (level 1)

Other Outcomes (15)

  • Change from the baseline serum C reactive protein level at 3 minutes post Yo-Yo intermittent recovery test (level 1)

    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)

    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)

    15 minutes before and 3 minutes after the Yo-Yo intermittent recovery test (level 1)

  • +12 more other outcomes

Study Arms (2)

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.

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.

Other: Yo-Yo intermittent recovery test (level 1)

Interventions

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

Athletes GroupSedentary Group

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University Faculty of Sport Sciences

Izmir, Turkey (Türkiye)

Location

Study Officials

  • Faruk Turgay, Assoc. Prof

    Ege University, Faculty of Sports Science

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior instructor

Study Record Dates

First Submitted

November 4, 2019

First Posted

November 7, 2019

Study Start

November 11, 2019

Primary Completion

September 2, 2020

Study Completion

September 7, 2020

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations