NCT04159194

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

September 30, 2019

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2019

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 12, 2019

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

April 18, 2023

Status Verified

September 1, 2019

Enrollment Period

17 days

First QC Date

September 10, 2019

Last Update Submit

April 14, 2023

Conditions

Keywords

soccerovertimeperformancerecovery

Outcome Measures

Primary Outcomes (15)

  • Measurement of countermovement jump height

    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

    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

    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.

    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

    At baseline

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Measurement of leukocyte counts

    Leukocyte counts will be measured on blood samples

    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

    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

    Change from baseline to 90 minutes and 120 minutes of the game.

Secondary Outcomes (3)

  • Measurement of reactive strength index

    At baseline

  • Measurement of blood lactate concentration

    Change from baseline to 90 minutes and 120 minutes of the game.

  • Measurement of glucose concentration in blood

    Change from baseline to 90 minutes and 120 minutes of the game.

Study Arms (2)

Normal CHO

ACTIVE COMPARATOR
Other: Control Diet

High CHO

EXPERIMENTAL
Other: Experimental Diet

Interventions

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.

Normal CHO

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)

High CHO

Eligibility Criteria

Age20 Years - 26 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Thessaly, School of Physical Education and Sports Science

Trikala, 42100, Greece

Location

Related Publications (2)

  • 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.

  • Mohr 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.

Study Officials

  • Ioannis G Fatouros, Prof

    University of Thessaly

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 10, 2019

First Posted

November 12, 2019

Study Start

September 30, 2019

Primary Completion

October 17, 2019

Study Completion

January 30, 2022

Last Updated

April 18, 2023

Record last verified: 2019-09

Locations