Protein Supplementation and Muscle Recovery in Football (PRO-FOOTBALL)

January 26, 2018 updated by: Athanasios Z. Jamurtas, University of Thessaly

Effect of Milk Protein Supplementation on Muscle Recovery and Football-specific Performance During an In-season Microcycle With Two Matches

Soccer is an intermittent sport including a high number of powerful actions such as accelerations, decelerations, changes of direction, jumps and impacts that incorporate a strong eccentric component and may therefore lead to skeletal muscle damage. Indeed, match activity is associated with the onset of muscle damage and an acute inflammatory response that result in attenuated performance for as long as 1 to 3 days. In competitive soccer though, multiple matches are performed within a small-time frame resulting in inadequate muscle recovery and reduced field performance. Supplementation with milk proteins following intense exercise protocols has been shown to stimulate protein synthesis and facilitate muscle recovery. Thus, the aim of the present investigation is to examine the effects of milk protein supplementation on muscle recovery and soccer-specific performance during an in-season microcycle with two matches performed three days apart.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In a double-blind, cross over, repeated measures design 20 men soccer players will receive either placebo (PLA) or milk protein isolate (PRO, 80% casein-20% whey) throughout recovery following two matches performed three days apart. On match days, players will receive a dose immediately after the match (PLA vs PRO: 25g of protein) and then at 3h (PLA vs PRO: 30g of protein) and 6h (PLA vs PRO: 25g of protein) post-match. On each day of the remaining days, players will consume a single dose of PLA or PRO (20g of protein) with breakfast. All players will participate in regular in-season training following matches. Field activity during both matches and daily practices will be monitored using GPS devices. Heart rate will be continuously recorded during each match and training session. Blood samples will be collected at baseline as well as 2 hours after the first match, daily for three days after the first match, 2 hours after the second match and daily for 3 days after the second match. Performance (isokinetic strength, 20-m speed, repeated sprint ability) and muscle soreness will be assessed at baseline daily for 3 days after both matches. Muscle biopsies from vastus lateralis will be collected at baseline and one day after each match.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Tríkala, Greece, 42100
        • Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • i) participation at elite level (top three division leagues) of soccer competition for at least five years, ii) abstain from consumption of performance-enhancing supplements, antioxidant supplements and medications (for at least 6 months before and during the study), iv) participate in at least six two-hour training sessions per week and played at least one match per week and v) non-smokers.

Exclusion Criteria:

  • i) a known milk intolerance or allergy, ii) a recent febrile illness, iii) history of muscle lesion, iv) lower limb trauma and v) metabolic diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Protein
On the match day, 25g of protein consumed immediately after the match and then 30g at 3h (+3h) and 25g at 6h (+6h). On each day of the remaining days, 20 g of protein consumed with breakfast.
Dietary supplement: Milk protein isolate
Milk protein isolate in a powder form consisted of 80% casein and 20% whey protein. 20g were diluted into 500 ml water
Active Comparator: Placebo
On the match day, 500 ml received received orally immediately post-match and then at +3h and +6h. On the remaining days, 500 ml daily with breakfast.
Dietary supplement: Placebo
500 mL drink that contained water (375 mL), sugar-free cordial (125 mL) and 2 g of low-calorie glucose/dextrose powder.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in creatine kinase in plasma
Time Frame: At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
Concentration of creatine kinase will be measured in plasma
At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
Change in uric acid in plasma
Time Frame: At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
Concentration of uric acid will be measured in plasma
At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
Change in protein carbonyls in blood
Time Frame: At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
Concentration of protein carbonyls will be measured in red blood cells
At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
Change in total antioxidant capacity
Time Frame: At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
Total antioxidant capacity will be measured in plasma
At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
Change in reduced glutathione in blood
Time Frame: At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
Concentration of reduced glutathione will be measured in in red blood cells
At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
Change in oxidized glutathione in blood
Time Frame: At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
Concentration of oxidized glutathione will be measured in red blood cells
At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
Change in malondialdehyde in blood
Time Frame: At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
Concentration of malondialdehyde will be measured in serum
At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
Change in catalase activity
Time Frame: At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
Catalase activity will be measured in red blood cells
At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
Change in protein carbonyls in muscle
Time Frame: At baseline, 24h post-Match 1 and 24h post-Match 2
Concentration of protein carbonyls will be measured in muscle
At baseline, 24h post-Match 1 and 24h post-Match 2
Change in intracellular signaling proteins in muscle
Time Frame: At baseline, 24h post-Match 1 and 24h post-Match 2
Phosphorylation levels of Akt, mammalian target of rapamycin (mTOR) and p70S6K will be measure using western blotting.
At baseline, 24h post-Match 1 and 24h post-Match 2
Change in proteasome activities in muscle
Time Frame: At baseline, 24h post-Match 1 and 24h post-Match 2
Chymotrypsin-like (CT-L), caspase-like (C-L) and trypsin-like (T-L) proteasome activities will be assayed with hydrolysis of the fluorogenic peptide LLVY-AMC, LLE-AMC and LSTR-AMC, respectively.
At baseline, 24h post-Match 1 and 24h post-Match 2
Change in satellite cells in muscle
Time Frame: At baseline, 24h post-Match 1 and 24h post-Match 2
Pax7, Myf5, MyoD and Myogenin will be measured in order to quantify quiescent, activated, proliferated-differentiated and fused satellite cells respectively.
At baseline, 24h post-Match 1 and 24h post-Match 2
Change in repeated Sprint Ability
Time Frame: At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
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.
At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
Change in countermovement jump
Time Frame: At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
Countermovement jump will be assessed on a contact platform
At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
Change in isokinetic strength of lower limbs
Time Frame: At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
Isokinetic strength will be assessed on an isokinetic dynamometer for both knee extensors and knee flexors at 120 and 180 degrees.
At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
Change in match activity
Time Frame: During Match 1 and Match 2
Match activity will be continuously recorded during both matches using GPS technology.
During Match 1 and Match 2
Change in heart rate
Time Frame: During Match 1 and Match 2
Heart rate will be continuously recorded during both matches using the Team Polar system.
During Match 1 and Match 2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dietary intake
Time Frame: Over a 7-day period at baseline.
Dietary intake will be assessed using 7-day diet recalls.
Over a 7-day period at baseline.
Change in delayed onset of muscle soreness
Time Frame: At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
Muscle soreness will assessed during palpation of the muscle belly and the distal region of relaxed vastus medialis, vastus lateralis and rectus femoris following three repetitions of of a full squat. Subjects will rate their DOMS on a visual analogue scale (0-10).
At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
Change in white blood cell count.
Time Frame: At baseline, immediately after Match 1, at 24h, 48h and 72h post-Match 1 as well as immediately after Match 2 and at 24h, 48h and 72h post-Match 2.
White blood cell count will be measured using an automatic blood analyzer.
At baseline, immediately after Match 1, at 24h, 48h and 72h post-Match 1 as well as immediately after Match 2 and at 24h, 48h and 72h post-Match 2.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Thessaly

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: ATHANASIOS POULIOS, PhDc, UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PROTEIN-FOOTBALL RECOVERY-UTH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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