Safety and Prevention of OveRTraining (SuPpOrt)

• ClinicalTrials.gov Identifier: NCT03833973
• Recruitment Status: Unknown
• First Posted: February 7, 2019
• Last Update Posted: December 27, 2019
• Sponsor: University of Thessaly
• Information provided by (Responsible Party): Ioannis G. Fatouros, University of Thessaly

Study Description

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.

Condition or disease	Intervention/treatment
Overtraining Syndrome	Behavioral: Overtraining Monitoring

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 Design

• Study Type: Observational
• Estimated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Evaluation of Cell-Free Plasma DNA (cfDNA) and Oxidative Stress Indices as Biomarkers for the Diagnosis and Prevention of Overtraining
• Actual Study Start Date: January 1, 2018
• Estimated Primary Completion Date: June 1, 2020
• Estimated Study Completion Date: July 30, 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. Change in Cortisol level [ Time Frame: At baseline, at six months and at twelve months ]
   Cortisol concentration will measured in serum
3. Change in Testosterone level [ Time Frame: At baseline, at six months and at twelve months ]
   Testosterone concentration will be measured in serum
4. 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.
5. 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
6. 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
7. 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
8. Change in total antioxidant capacity [ Time Frame: At baseline, at six months and at twelve months ]
   Total antioxidant capacity will be measured in plasma
9. 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
10. 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
11. Change in catalase activity [ Time Frame: At baseline, at six months and at twelve months ]
    Catalase activity will be measured in red blood cells
12. Change in malondialdehyde in blood [ Time Frame: At baseline, at six months and at twelve months ]
    Concentration of malondialdehyde will be measured in serum

Secondary Outcome Measures :

1. 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.
2. 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
3. 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.
4. Change in jumping ability. [ Time Frame: At baseline, at six months and at twelve months ]
   Jumping ability will be assessed by measuring squat jump.
5. Change in flexibility [ Time Frame: At baseline, at six months and at twelve months ]
   Flexibility will be assessed through the sit and reach test.
6. 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)
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.
13. Dietary intake [ Time Frame: At baseline, at six months and at twelve months ]
    Dietary intake will be assessed using 7-day diet recalls.
14. 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.
15. Change in jumping ability. [ Time Frame: At baseline, at six months and at twelve months ]
    Jumping ability will be assessed by measuring drop jump.

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 40 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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

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.

Contacts and Locations

Contacts

Contact: IOANNIS G FATOUROS, PhD; +30 24310 47047; ifatouros@pe.uth.gr

Contact: ATHANASIOS Z JAMURTAS, Prof; +30 24310 47054; ajamurt@pe.uth.gr

Locations

Greece

Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly; Recruiting

Tríkala, Greece, 42100

Contact: ATHANASIOS Z JAMURTAS, Prof +302431047054 ajamurt@pe.uth.gr

Contact: IOANNIS KOUTEDAKIS, Prof +302431047056 y.koutedakis@uth.gr

Sponsors and Collaborators

University of Thessaly

Investigators

• Principal Investigator: Vasiliki C Laschou, PhDc; UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES

More Information

• Responsible Party: Ioannis G. Fatouros, Professor, University of Thessaly
• ClinicalTrials.gov Identifier: NCT03833973
• Other Study ID Numbers: SuPpOrt-UTH
• First Posted: February 7, 2019
• Last Update Posted: December 27, 2019
• Last Verified: December 2019

• 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

Keywords provided by Ioannis G. Fatouros, University of Thessaly:

Training; Cell free plasma DNA; Oxidative stress; Performance