Aortic StiffnessNCT06590792
Relationship Between Oxidative Stress and Aortic Stiffness
A study testing exhaustive exercise training session in people with Aortic Stiffness and Oxidative Stress, run by Istanbul University at 2 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Aortic Stiffness, Oxidative Stress, Football Player
- What is being tested?
- exhaustive exercise training session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 30 May 2025to 15 Jul 2025
- 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 14 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- age between 14-18
- male gender
- football player
- attending regular football training for at least 1 season
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul Faculty of Medicine
Istanbul, 34093
Şensu Dinçer
Istanbul, 34093
About this study
Official title: Relationship Between Oxidative Stress and Aortic Stiffness During Acute Exhaustive Training in Adolescent Football Players
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.
Read the detailed description
Arterial stiffness is defined as stiffening of the arterial wall and refers to a decrease in the capacity of an artery to expand and contract in response to pressure changes in the vessel. The parameters indicating arterial stiffness are compliance and distensibility of the vessel.
Imbalance in the formation of vasodilator and vasoconstrictor signaling molecules acting on the vessel is an important determining factor in the development of endothelial dysfunction, which is often exacerbated by oxidative stress. Disruption of the balance between oxidants and antioxidants in favor of oxidants leads to disruption of the elastin-collagen ratio in the vessel wall in favor of collagen and ultimately to the development of arterial stiffness. Regular exercise is beneficial both to prevent the development of arterial stiffness and to reduce arterial stiffness. Although many mechanisms have been mentioned for exercise to improve endothelial function, there is no clear consensus on the mechanisms by which exercise increases arterial compliance, which is one of the indicators of atherosclerosis. While the beneficial impacts of physical activity on arterial stiffness are well-documented, this varies considerably among sports disciplines. For instance, there are studies showing that endurance training decreases arterial stiffness in young adults and elderly individuals, whereas strength training increases arterial stiffness. Arterial stiffness is lower in endurance athletes with a longer sports history and higher in those with a strength training history. The weekly training time of competitive young athletes is well beyond the amount of exercise required for healthy living. It has also been suggested that this excessive amount of time may trigger some unfavorable adaptations in the cardiovascular system. In addition, the number of studies examining the effects of regular exercise training at these levels on the vascular system is limited. Studies indicate that changes in arterial stiffness start at early ages and this is also true for young athletes who perform regular training in the infrastructures of various sports branches. Therefore, our aim is investigating the relationship between the oxidative stress parameters and aortic stiffness in adolescent male football players and comparing with the healthy control group. Secondly, the investigators will evaluate if there is any difference between the aortic stiffness and oxidative response to acute exercise training in adolescent male football players?
- Conditions
- Aortic Stiffness, Oxidative Stress, Football Player
- Being tested
- exhaustive exercise training session
- Keywords
- stiffness, elastography, football, oxidative stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exhaustive exercise training sessionOther
Cardiovascular exercise test will be performed by the participants. This test is sustained until the participants feel exhausted.
| Study group | Role | What they receive |
|---|---|---|
| football player | Experimental | 14-18 years old male football players who play in the infrastructure of a football club Receives: 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 Receives: Other: exhaustive exercise training session |
What is being measured
The primary outcome is the main question the study is designed to answer.
aortic strain (%)
=[(aortic systolic diameter - diastolic diameter)× 100] / aortic diastolic diameter
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: will be measured twice before and after acute exhaustive exercise,through study completion, up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 May 2025
- Primary completion30 Jun 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StiffnessStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şensu Dinçer, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590792
- Sponsor's protocol ID
- Soccer aortic stiffness
- Status last verified
- Aug 2025
- First submitted
- 4 Sep 2024
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Oxidative Stress and Aortic Stiffness During Acute Exhaustive Training in Adolescent Football Players
- ClinicalTrials.gov ID
- NCT06590792
- Acronym / sponsor ID
- Soccer aortic stiffness
- Conditions
- Aortic Stiffness, Oxidative Stress, Football Player
- Keywords
- stiffness, elastography, football, oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 19 Sep 2024 (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.
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.
Detailed description
Arterial stiffness is defined as stiffening of the arterial wall and refers to a decrease in the capacity of an artery to expand and contract in response to pressure changes in the vessel. The parameters indicating arterial stiffness are compliance and distensibility of the vessel.
Imbalance in the formation of vasodilator and vasoconstrictor signaling molecules acting on the vessel is an important determining factor in the development of endothelial dysfunction, which is often exacerbated by oxidative stress. Disruption of the balance between oxidants and antioxidants in favor of oxidants leads to disruption of the elastin-collagen ratio in the vessel wall in favor of collagen and ultimately to the development of arterial stiffness. Regular exercise is beneficial both to prevent the development of arterial stiffness and to reduce arterial stiffness. Although many mechanisms have been mentioned for exercise to improve endothelial function, there is no clear consensus on the mechanisms by which exercise increases arterial compliance, which is one of the indicators of atherosclerosis. While the beneficial impacts of physical activity on arterial stiffness are well-documented, this varies considerably among sports disciplines. For instance, there are studies showing that endurance training decreases arterial stiffness in young adults and elderly individuals, whereas strength training increases arterial stiffness. Arterial stiffness is lower in endurance athletes with a longer sports history and higher in those with a strength training history. The weekly training time of competitive young athletes is well beyond the amount of exercise required for healthy living. It has also been suggested that this excessive amount of time may trigger some unfavorable adaptations in the cardiovascular system. In addition, the number of studies examining the effects of regular exercise training at these levels on the vascular system is limited. Studies indicate that changes in arterial stiffness start at early ages and this is also true for young athletes who perform regular training in the infrastructures of various sports branches. Therefore, our aim is investigating the relationship between the oxidative stress parameters and aortic stiffness in adolescent male football players and comparing with the healthy control group. Secondly, the investigators will evaluate if there is any difference between the aortic stiffness and oxidative response to acute exercise training in adolescent male football players?
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| football player | Experimental | Other: exhaustive exercise training session14-18 years old male football players who play in the infrastructure of a football club |
| healthy control group | Active comparator | Other: exhaustive exercise training session14-18 years old male healthy participants who don't involve any regular sports training |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- age between 14-18
- male gender
- football player
- attending regular football training for at least 1 season
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| exhaustive exercise training sessionCardiovascular exercise test will be performed by the participants. This test is sustained until the participants feel exhausted. | Other | football player, healthy control group |
Primary outcome
aortic strain (%)
Time frame: will be measured twice before and after acute exhaustive exercise, through study completion, up to 8 weeks
=[(aortic systolic diameter - diastolic diameter)× 100] / aortic diastolic diameter
aortic stiffness index
Time frame: will be measured twice before and after acute exhaustive exercise,through study completion, up to 8 weeks
= ln (systolic pressure / diastolic pressure) / aortic strain
aortic distensibility (cm2.dyn-1.10-6)
Time frame: will be measured twice before and after acute exhaustive exercise,through study completion, up to 8 weeks
= (2 × aortic strain) / (systolic pressure-diastolic pressure)
serum lipid hydroperoxide assay
Time frame: will be measured twice before and after acute exhaustive exercise,through study completion, up to 8 weeks
lipid hydroperoxide (LHP) level of serum (nmol/mL). Lipid hydroperoxide (LOOH) is the first, comparatively stable, product of the lipid peroxidation reaction.
serum malondialdehide assay
Time frame: will be measured twice before and after acute exhaustive exercise,through study completion, up to 8 weeks
serum malondialdehide (MDA) level of serum (nmol/mL).MDA is the end product of the oxidation of polyunsaturated fatty acids.
serum advanced oxidation protein products assay
Time frame: will be measured twice before and after acute exhaustive exercise,through study completion, up to 8 weeks
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
serum advanced glycation end products assay
Time frame: will be measured twice before and after acute exhaustive exercise,through study completion, up to 8 weeks
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
serum ferric reducing antioxidant power assay
Time frame: will be measured twice before and after acute exhaustive exercise, through study completion, up to 8 weeks
ferric reducing antioxidant power (FRAP) level of serum (mikromol/mL ). FRAP is an antioxidant capacity assay that uses Trolox as a standard
serum superoxide dismutase activity assay
Time frame: will be measured twice before and after acute exhaustive exercise,through study completion, up to 8 weeks
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
serum total antioxidant status and total oxidant status assay
Time frame: will be measured twice before and after acute exhaustive exercise,through study completion, up to 8 weeks
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
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 11 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exhaustive exercise training session in people with Aortic Stiffness and Oxidative Stress, run by Istanbul University at 2 sites 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 4 inclusion and 4 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 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
aortic strain (%) (time frame: will be measured twice before and after acute exhaustive exercise, through study completion, up to 8 weeks). The study lists 10 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 11 Aug 2025.