Clinical trial NCT03833973: Safety and Prevention of OveRTraining
Official title: The Evaluation of Cell-Free Plasma DNA (cfDNA) and Oxidative Stress Indices as Biomarkers for the Diagnosis and Prevention of Overtraining
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Overtraining Syndrome
Keywords: Training
Cell free plasma DNA
Oxidative stress
Performance
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2019-02-07
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in cell free plasma DNA
timeFrame: At baseline, at six months and at twelve months
measure: Change in Cortisol level
timeFrame: At baseline, at six months and at twelve months
measure: Change in Testosterone level
timeFrame: At baseline, at six months and at twelve months
measure: Change in cytokine response
timeFrame: At baseline, at six months and at twelve months
measure: Change in creatine kinase in plasma
timeFrame: At baseline, at six months and at twelve months
measure: Change in uric acid in plasma
timeFrame: At baseline, at six months and at twelve months
measure: Change in protein carbonyls in blood
timeFrame: At baseline, at six months and at twelve months
measure: Change in total antioxidant capacity
timeFrame: At baseline, at six months and at twelve months
measure: Change in reduced glutathione in blood
timeFrame: At baseline, at six months and at twelve months
measure: Change in oxidized glutathione in blood
timeFrame: At baseline, at six months and at twelve months
measure: Change in catalase activity
timeFrame: At baseline, at six months and at twelve months
measure: Change in malondialdehyde in blood
timeFrame: At baseline, at six months and at twelve months
Secondary outcomes:
measure: Change in blood lactate concentration
timeFrame: At baseline, at six months and at twelve months
measure: Change in peak torque
timeFrame: At baseline, at six months and at twelve months
measure: Change in orthostatic heart rate.
timeFrame: At baseline, at six months and at twelve months
measure: Change in jumping ability.
timeFrame: At baseline, at six months and at twelve months
measure: Change in flexibility
timeFrame: At baseline, at six months and at twelve months
measure: Change in body composition.
timeFrame: At baseline, at six months and at twelve months
measure: Change in delay onset of muscle soreness (DOMS)
timeFrame: At baseline, at six months and at twelve months
measure: Change in complete blood count
timeFrame: At baseline, at six months and at twelve months
measure: Change in RSA
timeFrame: At baseline, at six months and at twelve months
measure: Change in Yo-Yo IE2
timeFrame: At baseline, at six months and at twelve months
measure: Change in Yo-Yo IR2
timeFrame: At baseline, at six months and at twelve months
measure: Change in Spreed
timeFrame: At baseline, at six months and at twelve months
measure: Dietary intake
timeFrame: At baseline, at six months and at twelve months
measure: Change in jumping ability.
timeFrame: At baseline, at six months and at twelve months
measure: Change in jumping ability.
timeFrame: At baseline, at six months and at twelve months
Other outcomes:
Locations:
city: Tríkala
country: Greece
facility: Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly
Study officials:
affiliation: UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES
name: Vasiliki C Laschou, PhDc
role: PRINCIPAL_INVESTIGATOR
References: