Safety and Prevention of OveRTraining (SuPpOrt)

December 26, 2019 updated by: Ioannis G. Fatouros, University of Thessaly

The Evaluation of Cell-Free Plasma DNA (cfDNA) and Oxidative Stress Indices as Biomarkers for the Diagnosis and Prevention of Overtraining

Athletic training aims to increase and improve physical performance that is achieved through training overload combined with periods of rest and recovery. Overtraining syndrome (OTS) is associated with an imbalance between training and recovery. The symptoms associated with OTS vary between individuals and may reflect parasympathetic and/or sympathetic nervous system alterations as well as endocrine irregularities. The prevalence is not known, but it is usually reported among endurance athletes, such as cyclists, distance runners and triathletes. It appears that OTS represents a systemic inflammatory process with diffuse effects on the neurohormonal axis affecting host immunology and mood. Previous works, showed that cell-free DNA (cf-DNA) is correlated with the severity of excessive exercise-induced inflammation as well as with trauma and stroke severity suggesting that it might be used as a potential clinical marker for athletes with overtraining syndrome. Oxidative stress indices can be determined non-invasively and may reflect inflammatory responses after training suggesting that they could be used as clinical markers for the diagnosis of OTS. However, there are no available biomarkers to aid towards the diagnosis and/or prevention of OTS, except that of the persistence of unexplained underperformance despite an extensive recovery of the athlete. Therefore, the purpose of this study is to evaluate the potential of cf-DNA and selected oxidative stress variables as diagnostic biomarkers of OTS.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A total number of 15 elite-level runners (both male and female) and 80-100 soccer players (both male and female) will participate in the study.The day when participants (runners) will arrive at the lab early in the morning, after an overnight fast. They will have their blood pressure and orthostatic heart rate measured and they will also provide a blood sample. Immediately after participants' body composition will be assessed by dual energy X-ray absorptiometry (DXA). Then, they will perform the Meeusen test providing a second blood sample immediately after the test. During the subsequent 4-hour resting period, the participants followed by assessment of joint mobility, delayed onset of muscle soreness, flexibility and vertical jump performance after that lower limb peak torque by isokinetic dynamometer. A second Meeusen test will take place after the resting period with blood sampling post-testing. Then, participants will have a 3-hour rest, after which they will visit the lab again in order to perform the running economy testing protocol and a maximal lactate steady state test. Finally, participants will complete POMS-, quality of sleep- and symptomatology-related questionnaires and will be taught on how to complete dietary recalls. Over the subsequent 12-month period participants will provide the investigator with a detailed report of their training plan and a symptomatology questionnaire every month. These measurements take place for all participants in two different periods, in transitional period/baseline and in middle season (berore tha main race). If someone of participants manifest the symptoms of overtraining, they perform the protocol of measurements again. The day when participants (soccer players) will arrive at the lab early in the morning, after an overnight fast. They will have their blood pressure and orthostatic heart rate measured and they will also provide a blood sample. Immediately after participants' body composition will be assessed by dual energy X-ray absorptiometry (DXA). The participants followed by assessment of joint mobility, delayed onset of muscle soreness, flexibility and vertical jump performance after that lower limb peak torque by isokinetic dynamometer. After resting, they will measurement the maximum oxygen uptake in stress test on the aisle. The next days, in football players take place in field tests, will measure the Speed in 10, 30 meters, Yo-Yo IE2 (Intermittent Endurance 2), Yo-Yo IR2 (Intermittent Recovery 2) and Repeated Sprint Ability (RSA). Finally, participants (soccer players) will complete POMS-, quality of sleep- and symptomatology-related questionnaires and will be taught on how to complete dietary recalls.These measurements take place for all participants in two different periods, in transitional period/baseline and in middle season (berore tha main race). If someone of participants manifest the symptoms of overtraining, they perform the protocol again.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Greece
      • Tríkala, Greece, 42100
        • Recruiting
        • Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 40 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants for the first group will be male and female long-distance, marathon, 5 km and 10 km runners aged 20-40 years. All of them will be active, elite-level runners , participating in regular competitive training. For the second group will be male and female high level soccer players aged 15-30 years

Description

Inclusion Criteria for Runners:

Participants:

  • should be long-distance runners, marathon runners, 5 km and 10 km runners.
  • should be able to provide the daily training plan and a 7-day dietary recall every month.
  • should be considered elite level runners.
  • should be free of musculoskeletal injuries for at least one year before the study.

Inclusion Criteria for Soccer Players:

Participants:

  • should be elite soccer players.
  • should be able to provide the daily training plan and a 7-day dietary recall.
  • should be participated in matches.
  • should be free of musculoskeletal injuries for at least one year before the study.

Exclusion Criteria (both Runners and Soccer Players):

If participants:

  • do not adhere to rules of the study.
  • have a recent history of illness or injury .
  • do not participate in competitive training.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Runners
Long-distance runners, marathon runners, 5 km and 10 km runners, both female and male aged 20 - 40 years, participating in regular training and competitions.
Behavioral: Overtraining Monitoring
Athletes will be thoroughly monitored (i.e. training workload, match activities or event/race performance, markers of inflammation and oxidative stress as well as cell-free DNA) throughout the season in order to establish novel biomarkers that could function as either predictors or diagnostic tools of overtraining.
Soccer Players
High Level soccer players, both female and male aged 15-30, participating in all games
Behavioral: Overtraining Monitoring
Athletes will be thoroughly monitored (i.e. training workload, match activities or event/race performance, markers of inflammation and oxidative stress as well as cell-free DNA) throughout the season in order to establish novel biomarkers that could function as either predictors or diagnostic tools of overtraining.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in cell free plasma DNA
Time Frame: At baseline, at six months and at twelve months
Cell free plasma DNA will be measured with real-time PCR in plasma samples.
At baseline, at six months and at twelve months
Change in Cortisol level
Time Frame: At baseline, at six months and at twelve months
Cortisol concentration will measured in serum
At baseline, at six months and at twelve months
Change in Testosterone level
Time Frame: At baseline, at six months and at twelve months
Testosterone concentration will be measured in serum
At baseline, at six months and at twelve months
Change in cytokine response
Time Frame: At baseline, at six months and at twelve months
Concentration of TNF-α, IL-6 and IL-10 will be measured in plasma.
At baseline, at six months and at twelve months
Change in creatine kinase in plasma
Time Frame: At baseline, at six months and at twelve months
Concentration of creatine kinase will be measured in plasma
At baseline, at six months and at twelve months
Change in uric acid in plasma
Time Frame: At baseline, at six months and at twelve months
Concentration of uric acid will be measured in plasma
At baseline, at six months and at twelve months
Change in protein carbonyls in blood
Time Frame: At baseline, at six months and at twelve months
Concentration of protein carbonyls will be measured in red blood cells
At baseline, at six months and at twelve months
Change in total antioxidant capacity
Time Frame: At baseline, at six months and at twelve months
Total antioxidant capacity will be measured in plasma
At baseline, at six months and at twelve months
Change in reduced glutathione in blood
Time Frame: At baseline, at six months and at twelve months
Concentration of reduced glutathione will be measured in in red blood cells
At baseline, at six months and at twelve months
Change in oxidized glutathione in blood
Time Frame: At baseline, at six months and at twelve months
Concentration of oxidized glutathione will be measured in red blood cells
At baseline, at six months and at twelve months
Change in catalase activity
Time Frame: At baseline, at six months and at twelve months
Catalase activity will be measured in red blood cells
At baseline, at six months and at twelve months
Change in malondialdehyde in blood
Time Frame: At baseline, at six months and at twelve months
Concentration of malondialdehyde will be measured in serum
At baseline, at six months and at twelve months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in blood lactate concentration
Time Frame: At baseline, at six months and at twelve months
Blood lactate concentration will be measured during a maximal lactate steady-state test.
At baseline, at six months and at twelve months
Change in peak torque
Time Frame: At baseline, at six months and at twelve months
Peak torque will be assessed on an isokinetic dynamometer at 60 degrees/sec
At baseline, at six months and at twelve months
Change in orthostatic heart rate.
Time Frame: At baseline, at six months and at twelve months
Heart rate will be measured in a resting position and following 15 seconds of standing by heart rate monitor.
At baseline, at six months and at twelve months
Change in jumping ability.
Time Frame: At baseline, at six months and at twelve months
Jumping ability will be assessed by measuring squat jump.
At baseline, at six months and at twelve months
Change in flexibility
Time Frame: At baseline, at six months and at twelve months
Flexibility will be assessed through the sit and reach test.
At baseline, at six months and at twelve months
Change in body composition.
Time Frame: At baseline, at six months and at twelve months
Body composition will be assessed by dual energy X-ray absorptiometry (DXA)
At baseline, at six months and at twelve months
Change in delay onset of muscle soreness (DOMS)
Time Frame: At baseline, at six months and at twelve months
DOMS will be assessed by muscle palpation while participants are laying , standing and after performing 3 squats.
At baseline, at six months and at twelve months
Change in complete blood count
Time Frame: At baseline, at six months and at twelve months
Complete blood count analysis will be performed on an automatic blood analyzer.
At baseline, at six months and at twelve months
Change in RSA
Time Frame: At baseline, at six months and at twelve months
5 x 30 m sprints will be performed with 25 seconds rest in-between. Mean time for 5 sprints and fatigue index will be calculated.
At baseline, at six months and at twelve months
Change in Yo-Yo IE2
Time Frame: At baseline, at six months and at twelve months
Yo-Yo IE2 will be assessed using a standardized testing protocol.
At baseline, at six months and at twelve months
Change in Yo-Yo IR2
Time Frame: At baseline, at six months and at twelve months
Yo-Yo IR2 will be assessed using a standardized testing protocol.
At baseline, at six months and at twelve months
Change in Spreed
Time Frame: At baseline, at six months and at twelve months
Spreed will be assessed using a standardized testing protocol in 10 and 30 meters.
At baseline, at six months and at twelve months
Dietary intake
Time Frame: At baseline, at six months and at twelve months
Dietary intake will be assessed using 7-day diet recalls.
At baseline, at six months and at twelve months
Change in jumping ability.
Time Frame: At baseline, at six months and at twelve months
Jumping ability will be assessed by measuring counter-movement jump.
At baseline, at six months and at twelve months
Change in jumping ability.
Time Frame: At baseline, at six months and at twelve months
Jumping ability will be assessed by measuring drop jump.
At baseline, at six months and at twelve months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Thessaly

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vasiliki C Laschou, PhDc, UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 27, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SuPpOrt-UTH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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