NCT06590792

Brief Summary

The goal of this clinical trial is to search about if there is any relationship between the aortic stiffness and oxidative stress response in adolescent football players. The main questions are;

  • Is there any difference between the adolescent football players and healthy sedentary control group in terms of oxidative stress and aortic stiffness parameters?
  • Is there any relationship between the aortic stiffness and oxidative response to acute exercise training in adolescent male football players? Participants will perform acute exhaustive exercise training. Venous blood will be drained before and after exercise training. Oxidative parameters will be measured.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

September 4, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

May 30, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

1 month

First QC Date

September 4, 2024

Last Update Submit

August 8, 2025

Conditions

Keywords

stiffnesselastographyfootballoxidative stress

Outcome Measures

Primary Outcomes (10)

  • aortic strain (%)

    =\[(aortic systolic diameter - diastolic diameter)× 100\] / aortic diastolic diameter

    will be measured twice before and after acute exhaustive exercise, through study completion, up to 8 weeks

  • aortic stiffness index

    = ln (systolic pressure / diastolic pressure) / aortic strain

    will be measured twice before and after acute exhaustive exercise,through study completion, up to 8 weeks

  • aortic distensibility (cm2.dyn-1.10-6)

    = (2 × aortic strain) / (systolic pressure-diastolic pressure)

    will be measured twice before and after acute exhaustive exercise,through study completion, up to 8 weeks

  • serum lipid hydroperoxide assay

    lipid hydroperoxide (LHP) level of serum (nmol/mL). Lipid hydroperoxide (LOOH) is the first, comparatively stable, product of the lipid peroxidation reaction.

    will be measured twice before and after acute exhaustive exercise,through study completion, up to 8 weeks

  • serum malondialdehide assay

    serum malondialdehide (MDA) level of serum (nmol/mL).MDA is the end product of the oxidation of polyunsaturated fatty acids.

    will be measured twice before and after acute exhaustive exercise,through study completion, up to 8 weeks

  • serum advanced oxidation protein products assay

    Advanced oxidation protein products (AOPP) level of serum (mikromol/L ). AOPP are the dityrosine-containing and crosslinking protein products formed during oxidative stress by reaction of plasma protein with chlorinated oxidants, and often carried by albumin in vivo

    will be measured twice before and after acute exhaustive exercise,through study completion, up to 8 weeks

  • serum advanced glycation end products assay

    serum advanced glycation end products (AGE) level of serum(FU/mg). AGEs are are a heterogeneous group of proteins and lipids, formed by nonenzymatic glycation after persistent contact with aldose sugars

    will be measured twice before and after acute exhaustive exercise,through study completion, up to 8 weeks

  • serum ferric reducing antioxidant power assay

    ferric reducing antioxidant power (FRAP) level of serum (mikromol/mL ). FRAP is an antioxidant capacity assay that uses Trolox as a standard

    will be measured twice before and after acute exhaustive exercise, through study completion, up to 8 weeks

  • serum superoxide dismutase activity assay

    copper-zinc superoxide dismutase activity (SOD) level of serum (U/mL). SODs are enzymes that catalyze the conversion of naturally-occuring but harmful superoxide radicals into molecular oxygen and hydrogen peroxide

    will be measured twice before and after acute exhaustive exercise,through study completion, up to 8 weeks

  • serum total antioxidant status and total oxidant status assay

    total antioxidant status (TAS) and total oxidant status (TOS) levels of serum (trolox equivalent/L) are two indicators to determine all antioxidants or oxidants in samples, which can more comprehensively reflect the changes of oxidant and antioxidant capacity of samples

    will be measured twice before and after acute exhaustive exercise,through study completion, up to 8 weeks

Study Arms (2)

football player

EXPERIMENTAL

14-18 years old male football players who play in the infrastructure of a football club

Other: exhaustive exercise training session

healthy control group

ACTIVE COMPARATOR

14-18 years old male healthy participants who don't involve any regular sports training

Other: exhaustive exercise training session

Interventions

Cardiovascular exercise test will be performed by the participants. This test is sustained until the participants feel exhausted.

football playerhealthy control group

Eligibility Criteria

Age14 Years - 18 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age between 14-18
  • male gender
  • football player
  • attending regular football training for at least 1 season

You may not qualify if:

  • female gender
  • attending any other sports training except from football
  • having any chronic disease
  • having any musculoskeletal disease which limits to join exhaustive exercise training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istanbul Faculty of Medicine

Istanbul, 34093, Turkey (Türkiye)

Location

Şensu Dinçer

Istanbul, 34093, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Echocardiographer and biochemistry expert will be blind to participants type (sedentary or football player)
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Two groups including 20 participants in each of them will be involved the study. One group will consist of adolescent football players, while the other group will consist of non-athlete healthy participants
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

September 4, 2024

First Posted

September 19, 2024

Study Start

May 30, 2025

Primary Completion

June 30, 2025

Study Completion

July 15, 2025

Last Updated

August 11, 2025

Record last verified: 2025-08

Locations