Metabolic StressSOCCER-120NCT04159194
Analysis of Overtime in Soccer
A study testing Experimental Diet in people with Metabolic Stress, run by University of Thessaly at 1 site in Greece.
Trial summary
A randomized, two-trial (placebo vs. supplement consumption), cross-over, double-blind, repeated measures design will be applied to study i) the performance, metabolic and inflammatory overload of overtime in soccer and ii) how carbohydrate supplementation affects recovery following a football match with overtime. Read more about this study
- Who is it for?
- Ages 20 to 26 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Stress
- What is being tested?
- Experimental Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- 30 Sep 2019to 30 Jan 2022
- 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 20 to 26 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- competitive level for ≥4 years (≥5 training sessions/week, ≥1 match/week)
- no recent history of febrile illness, muscle lesions, lower limb trauma, and metabolic diseases
- no use of ergogenic supplements and medication (for ≥6 prior to the study)
- non-smokers
Who cannot join
- recent history of febrile illness, muscle lesions, lower limb trauma, and metabolic diseases
- use of ergogenic supplements and medication (for ≥6 prior to the study)
- smoking
- competitive level for < 4 years
Trial locations and contacts
1 site in 1 country.
Greece1 site
University of Thessaly, School of Physical Education and Sports Science
Trikala, 42100
About this study
Official title: Performance and Physiological Analysis of Overtime in Soccer: Implications for Recovery and Training
A randomized, two-trial (placebo vs. supplement consumption), cross-over, double-blind, repeated measures design will be applied to study i) the performance, metabolic and inflammatory overload of overtime in soccer and ii) how carbohydrate supplementation affects recovery following a football match with overtime. The study will be performed during a brake of the in-season period to mimic a real life setting. A 10-day washout period will be utilized between trials.
Read the detailed description
Initially and before the familiarization period, measurement of descriptive variables will be performed: body composition, maximal oxygen consumption, football-specific endurance via YO-YO IE2 and IR2, technical performance, daily diet intake, resting metabolic rate (canopy method), and daily physical activity (IPAQ questionnaire). At this time, volunteers (of equal technical, tactical and physical potential) will be randomly assigned (equally representing all field positions) to two teams.
A 7-day familiarization period will be applied initially during which participants will be accustomed with research procedures, match tactics, and diet (a standard diet will be given based on their dietary analysis, RMR measurement and daily energy expenditure). During this adaptive period, volunteers will participated in light training aimed at developing team cohesion.
Thereafter, the two experimental trials will take place. Each trial will include administration of either a high carbohydrate diet (CHO trial) or standard diet (control trial) and they will be carried out in a random order for each participant. Each trial will included two 120-min matches (M1 and M2) performed 3 days apart according to UEFA official schedules for National teams' tournaments. On match days, volunteers will participate only in morning testing sessions but not practice. Prior to each game, a standard breakfast and meal will be consumed. During each match, players will be allowed to drink only water ad libitum and their water intake will be recorded. Sweat loss during the match will be determined by measuring players' body mass wearing dry shorts immediately before the match, at half time, immediately after the match and immediately after each half of the overtime. Two practice sessions will take place on days 1 and 2 between M1 and M2 designed according to the training model routinely adapted by national football teams during the UEFA EURO tournament. Matches will be organized according to official UEFA regulations. Field activity during matches and practices will be recorded using high time-resolution GPS instrumentation and heart rate monitoring. Following M1 and for the next 3 days until M2, participants will receive either carbohydrate or placebo. Diet intake will be monitored daily throughout the study.
Performance assessments will be performed post-matches and daily between matches.
Blood samples will be collected at baseline as well as at 90 and 120 min of each match and before M2.
Muscle biopsies will be collected at baseline as well as at 90 and 120 min of M1 and before M2.
- Conditions
- Metabolic Stress
- Being tested
- Control Diet, Experimental Diet
- Keywords
- soccer, overtime, performance, recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control DietOther
Players during the control trial will be instructed to maintain their normal food intake (~55% CHO) and the type and amount of ingested food will be recorded.
Experimental DietOther
The experimental diet will be administered by the investigators after M1, daily for the next 48 hours (three main meals, i.e. breakfast, lunch, and dinner, and snacks such as energy bars and raisins), and before M2 (breakfast and lunch)
| Study group | Role | What they receive |
|---|---|---|
| Normal CHO | Active comparator | Not described Receives: Other: Control Diet |
| High CHO | Experimental | Not described Receives: Other: Experimental Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of countermovement jump height
Measured: Change from baseline to 90 minutes and 120 minutes of the game.
Measurement of maximal sprinting speed over 10 meters
10-m sprinting speed will be assessed on the soccer field by utilizing light cells
Measured: Change from baseline to 90 minutes and 120 minutes of the game.
Measurement of maximal sprinting speed over 30 meters
30-m sprinting speed will be assessed on the soccer field by utilizing light cells
Measured: Change from baseline to 90 minutes and 120 minutes of the game.
Measurement of the capacity to perform repeated sprints
5 x 30m repeated maximal sprints will be performed with 30 sec rest in between. Speed will be recorded by utilizing light cells.
Measured: Change from baseline to 90 minutes and 120 minutes of the game.
Measurement of isometric maximal voluntary contraction
Isometric maximal voluntary contraction will be assessed on an isokinetic dynamometer
Measured: At baseline
Measurement of total protein content
Total protein content will be assessed on muscle biopsy samples
Measured: Change from baseline to 90 minutes and 120 minutes of the game.
Measurement of muscle glycogen content
Muscle glycogen content will be assessed on muscle biopsy samples
Measured: Change from baseline to 90 minutes and 120 minutes of the game.
Measurement of muscle phosphocreatine content
Muscle phosphocreatine levels will be assessed on muscle biopsy samples
Measured: Change from baseline to 90 minutes and 120 minutes of the game.
Measurement of muscle lactate concentration
Muscle lactate concentration will be assessed on muscle biopsy samples
Measured: Change from baseline to 90 minutes and 120 minutes of the game.
Measurement of Na+ - K+ ATPase levels
Muscle Na+ - K+ ATPase levels will be assessed on muscle biopsy samples
Measured: Change from baseline to 90 minutes and 120 minutes of the game.
Measurement of creatine kinase activity
Creatine kinase activity will be measured on blood samples
Measured: Change from baseline to 90 minutes and 120 minutes of the game.
Measurement of C-reactive protein levels
C-reactive protein levels will be measured on blood samples
Measured: Change from baseline to 90 minutes and 120 minutes of the game.
Measurement of leukocyte counts
Leukocyte counts will be measured on blood samples
Measured: Change from baseline to 90 minutes and 120 minutes of the game.
Measurement of Interleukin-6 levels
Interleukin-6 levels will be measured on blood samples
Measured: Change from baseline to 90 minutes and 120 minutes of the game.
Measurement of Tumor necrosis factor - α levels
Tumor necrosis factor - α levels will be measured on blood samples
Measured: Change from baseline to 90 minutes and 120 minutes of the game.
Secondary outcomes (3)
Measurement of reactive strength index
Measured: At baseline
Measurement of blood lactate concentration
Lactate concentration will be measured on blood samples
Measured: Change from baseline to 90 minutes and 120 minutes of the game.
Measurement of glucose concentration in blood
Glucose concentration will be measured on blood samples
Measured: Change from baseline to 90 minutes and 120 minutes of the game.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start30 Sep 2019
- Primary completion17 Oct 2019
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic StressStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ioannis G. Fatouros, University of Thessaly
- Investigators
- Ioannis G Fatouros, Prof, Principal investigator, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159194
- Sponsor's protocol ID
- SOCCER-OVERTIME-UTH 2019
- Acronym
- SOCCER-120
- Status last verified
- Sep 2019
- First submitted
- 10 Sep 2019
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ermidis G, Mohr M, Jamurtas AZ, Draganidis D, Poulios A, Papanikolaou K, Vigh-Larsen JF, Loules G, Sovatzidis A, Nakopoulou T, Tsimeas P, Douroudos II, Papadopoulos C, Papadimas G, Rosvoglou A, Liakou C, Deli CK, Georgakouli K, Chatzinikolaou A, Krustrup P, Fatouros IG. Recovery during Successive 120-min Football Games: Results from the 120-min Placebo/Carbohydrate Randomized Controlled Trial. Med Sci Sports Exerc. 2024 Jun 1;56(6):1094-1107. doi: 10.1249/MSS.0000000000003398. Epub 2024 Jan 30.
PubMed 38306312Mohr M, Ermidis G, Jamurtas AZ, Vigh-Larsen JF, Poulios A, Draganidis D, Papanikolaou K, Tsimeas P, Batsilas D, Loules G, Batrakoulis A, Sovatzidis A, Nielsen JL, Tzatzakis T, Deli CK, Nybo L, Krustrup P, Fatouros IG. Extended Match Time Exacerbates Fatigue and Impacts Physiological Responses in Male Soccer Players. Med Sci Sports Exerc. 2023 Jan 1;55(1):80-92. doi: 10.1249/MSS.0000000000003021. Epub 2022 Aug 12.
PubMed 35977104
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance and Physiological Analysis of Overtime in Soccer: Implications for Recovery and Training
- ClinicalTrials.gov ID
- NCT04159194
- Acronym / sponsor ID
- SOCCER-120 / SOCCER-OVERTIME-UTH 2019
- Conditions
- Metabolic Stress
- Keywords
- soccer, overtime, performance, recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 17 Oct 2019 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 12 Nov 2019 (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.
A randomized, two-trial (placebo vs. supplement consumption), cross-over, double-blind, repeated measures design will be applied to study i) the performance, metabolic and inflammatory overload of overtime in soccer and ii) how carbohydrate supplementation affects recovery following a football match with overtime. The study will be performed during a brake of the in-season period to mimic a real life setting. A 10-day washout period will be utilized between trials.
Detailed description
Initially and before the familiarization period, measurement of descriptive variables will be performed: body composition, maximal oxygen consumption, football-specific endurance via YO-YO IE2 and IR2, technical performance, daily diet intake, resting metabolic rate (canopy method), and daily physical activity (IPAQ questionnaire). At this time, volunteers (of equal technical, tactical and physical potential) will be randomly assigned (equally representing all field positions) to two teams.
A 7-day familiarization period will be applied initially during which participants will be accustomed with research procedures, match tactics, and diet (a standard diet will be given based on their dietary analysis, RMR measurement and daily energy expenditure). During this adaptive period, volunteers will participated in light training aimed at developing team cohesion.
Thereafter, the two experimental trials will take place. Each trial will include administration of either a high carbohydrate diet (CHO trial) or standard diet (control trial) and they will be carried out in a random order for each participant. Each trial will included two 120-min matches (M1 and M2) performed 3 days apart according to UEFA official schedules for National teams' tournaments. On match days, volunteers will participate only in morning testing sessions but not practice. Prior to each game, a standard breakfast and meal will be consumed. During each match, players will be allowed to drink only water ad libitum and their water intake will be recorded. Sweat loss during the match will be determined by measuring players' body mass wearing dry shorts immediately before the match, at half time, immediately after the match and immediately after each half of the overtime. Two practice sessions will take place on days 1 and 2 between M1 and M2 designed according to the training model routinely adapted by national football teams during the UEFA EURO tournament. Matches will be organized according to official UEFA regulations. Field activity during matches and practices will be recorded using high time-resolution GPS instrumentation and heart rate monitoring. Following M1 and for the next 3 days until M2, participants will receive either carbohydrate or placebo. Diet intake will be monitored daily throughout the study.
Performance assessments will be performed post-matches and daily between matches.
Blood samples will be collected at baseline as well as at 90 and 120 min of each match and before M2.
Muscle biopsies will be collected at baseline as well as at 90 and 120 min of M1 and before M2.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal CHO | Active comparator | Other: Control Diet |
| High CHO | Experimental | Other: Experimental Diet |
Who may qualify
- Ages
- 20 to 26 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- competitive level for ≥4 years (≥5 training sessions/week, ≥1 match/week)
- no recent history of febrile illness, muscle lesions, lower limb trauma, and metabolic diseases
- no use of ergogenic supplements and medication (for ≥6 prior to the study)
- non-smokers
Key exclusion criteria (4 listed)
- recent history of febrile illness, muscle lesions, lower limb trauma, and metabolic diseases
- use of ergogenic supplements and medication (for ≥6 prior to the study)
- smoking
- competitive level for < 4 years
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 |
|---|---|---|
| Control DietPlayers during the control trial will be instructed to maintain their normal food intake (~55% CHO) and the type and amount of ingested food will be recorded. | Other | Normal CHO |
| Experimental DietThe experimental diet will be administered by the investigators after M1, daily for the next 48 hours (three main meals, i.e. breakfast, lunch, and dinner, and snacks such as energy bars and raisins), and before M2 (breakfast and lunch) | Other | High CHO |
Primary outcome
Measurement of countermovement jump height
Time frame: Change from baseline to 90 minutes and 120 minutes of the game.
Measurement of maximal sprinting speed over 10 meters
Time frame: Change from baseline to 90 minutes and 120 minutes of the game.
10-m sprinting speed will be assessed on the soccer field by utilizing light cells
Measurement of maximal sprinting speed over 30 meters
Time frame: Change from baseline to 90 minutes and 120 minutes of the game.
30-m sprinting speed will be assessed on the soccer field by utilizing light cells
Measurement of the capacity to perform repeated sprints
Time frame: Change from baseline to 90 minutes and 120 minutes of the game.
5 x 30m repeated maximal sprints will be performed with 30 sec rest in between. Speed will be recorded by utilizing light cells.
Measurement of isometric maximal voluntary contraction
Time frame: At baseline
Isometric maximal voluntary contraction will be assessed on an isokinetic dynamometer
Measurement of total protein content
Time frame: Change from baseline to 90 minutes and 120 minutes of the game.
Total protein content will be assessed on muscle biopsy samples
Measurement of muscle glycogen content
Time frame: Change from baseline to 90 minutes and 120 minutes of the game.
Muscle glycogen content will be assessed on muscle biopsy samples
Measurement of muscle phosphocreatine content
Time frame: Change from baseline to 90 minutes and 120 minutes of the game.
Muscle phosphocreatine levels will be assessed on muscle biopsy samples
Measurement of muscle lactate concentration
Time frame: Change from baseline to 90 minutes and 120 minutes of the game.
Muscle lactate concentration will be assessed on muscle biopsy samples
Measurement of Na+ - K+ ATPase levels
Time frame: Change from baseline to 90 minutes and 120 minutes of the game.
Muscle Na+ - K+ ATPase levels will be assessed on muscle biopsy samples
Measurement of creatine kinase activity
Time frame: Change from baseline to 90 minutes and 120 minutes of the game.
Creatine kinase activity will be measured on blood samples
Measurement of C-reactive protein levels
Time frame: Change from baseline to 90 minutes and 120 minutes of the game.
C-reactive protein levels will be measured on blood samples
Measurement of leukocyte counts
Time frame: Change from baseline to 90 minutes and 120 minutes of the game.
Leukocyte counts will be measured on blood samples
Measurement of Interleukin-6 levels
Time frame: Change from baseline to 90 minutes and 120 minutes of the game.
Interleukin-6 levels will be measured on blood samples
Measurement of Tumor necrosis factor - α levels
Time frame: Change from baseline to 90 minutes and 120 minutes of the game.
Tumor necrosis factor - α levels will be measured on blood samples
3 secondary outcomes
Measurement of reactive strength index
Time frame: At baseline
Measurement of blood lactate concentration
Time frame: Change from baseline to 90 minutes and 120 minutes of the game.
Measurement of glucose concentration in blood
Time frame: Change from baseline to 90 minutes and 120 minutes of the game.
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 18 Apr 2023.
- Derived from this study: PubMed 38306312Ermidis G, Mohr M, Jamurtas AZ, Draganidis D, Poulios A, Papanikolaou K, Vigh-Larsen JF, Loules G, Sovatzidis A, Nakopoulou T, Tsimeas P, Douroudos II, Papadopoulos C, Papadimas G, Rosvoglou A, Liakou C, Deli CK, Georgakouli K, Chatzinikolaou A, Krustrup P, Fatouros IG. Recovery during Successive 120-min Football Games: Results from the 120-min Placebo/Carbohydrate Randomized Controlled Trial. Med Sci Sports Exerc. 2024 Jun 1;56(6):1094-1107. doi: 10.1249/MSS.0000000000003398. Epub 2024 Jan 30.
- Derived from this study: PubMed 35977104Mohr M, Ermidis G, Jamurtas AZ, Vigh-Larsen JF, Poulios A, Draganidis D, Papanikolaou K, Tsimeas P, Batsilas D, Loules G, Batrakoulis A, Sovatzidis A, Nielsen JL, Tzatzakis T, Deli CK, Nybo L, Krustrup P, Fatouros IG. Extended Match Time Exacerbates Fatigue and Impacts Physiological Responses in Male Soccer Players. Med Sci Sports Exerc. 2023 Jan 1;55(1):80-92. doi: 10.1249/MSS.0000000000003021. Epub 2022 Aug 12.
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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.
Ioannis G Fatouros, Prof principal investigator
University of Thessaly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Diet in people with Metabolic Stress, run by University of Thessaly at 1 site in Greece.
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 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
Measurement of countermovement jump height (time frame: Change from baseline to 90 minutes and 120 minutes of the game.). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04159194, which also lists 2 linked publications.
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 18 Apr 2023.