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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04159194
Other study ID # SOCCER-OVERTIME-UTH 2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 30, 2019
Est. completion date January 30, 2022

Study information

Verified date September 2019
Source University of Thessaly
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 30, 2022
Est. primary completion date October 17, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 26 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Control Diet
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 Diet
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)

Locations

Country Name City State
Greece University of Thessaly, School of Physical Education and Sports Science Trikala

Sponsors (1)

Lead Sponsor Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of countermovement jump height Change from baseline to 90 minutes and 120 minutes of the game.
Primary Measurement of maximal sprinting speed over 10 meters 10-m sprinting speed will be assessed on the soccer field by utilizing light cells Change from baseline to 90 minutes and 120 minutes of the game.
Primary Measurement of maximal sprinting speed over 30 meters 30-m sprinting speed will be assessed on the soccer field by utilizing light cells Change from baseline to 90 minutes and 120 minutes of the game.
Primary 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. Change from baseline to 90 minutes and 120 minutes of the game.
Primary Measurement of isometric maximal voluntary contraction Isometric maximal voluntary contraction will be assessed on an isokinetic dynamometer At baseline
Primary Measurement of total protein content Total protein content will be assessed on muscle biopsy samples Change from baseline to 90 minutes and 120 minutes of the game.
Primary Measurement of muscle glycogen content Muscle glycogen content will be assessed on muscle biopsy samples Change from baseline to 90 minutes and 120 minutes of the game.
Primary Measurement of muscle phosphocreatine content Muscle phosphocreatine levels will be assessed on muscle biopsy samples Change from baseline to 90 minutes and 120 minutes of the game.
Primary Measurement of muscle lactate concentration Muscle lactate concentration will be assessed on muscle biopsy samples Change from baseline to 90 minutes and 120 minutes of the game.
Primary Measurement of Na+ - K+ ATPase levels Muscle Na+ - K+ ATPase levels will be assessed on muscle biopsy samples Change from baseline to 90 minutes and 120 minutes of the game.
Primary Measurement of creatine kinase activity Creatine kinase activity will be measured on blood samples Change from baseline to 90 minutes and 120 minutes of the game.
Primary Measurement of C-reactive protein levels C-reactive protein levels will be measured on blood samples Change from baseline to 90 minutes and 120 minutes of the game.
Primary Measurement of leukocyte counts Leukocyte counts will be measured on blood samples Change from baseline to 90 minutes and 120 minutes of the game.
Primary Measurement of Interleukin-6 levels Interleukin-6 levels will be measured on blood samples Change from baseline to 90 minutes and 120 minutes of the game.
Primary Measurement of Tumor necrosis factor - a levels Tumor necrosis factor - a levels will be measured on blood samples Change from baseline to 90 minutes and 120 minutes of the game.
Secondary Measurement of reactive strength index At baseline
Secondary Measurement of blood lactate concentration Lactate concentration will be measured on blood samples Change from baseline to 90 minutes and 120 minutes of the game.
Secondary Measurement of glucose concentration in blood Glucose concentration will be measured on blood samples Change from baseline to 90 minutes and 120 minutes of the game.
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