- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03348267
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
Completed
Intervention / Treatment
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
Interventional
Enrollment (Actual)
20
Phase
- 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
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Tríkala, Greece, 42100
- Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly
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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
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 |
Intervention / Treatment |
|---|---|
|
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.
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Milk protein isolate in a powder form consisted of 80% casein and 20% whey protein.
20g were diluted into 500 ml water
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|
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.
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500 mL drink that contained water (375 mL), sugar-free cordial (125 mL) and 2 g of low-calorie glucose/dextrose powder.
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What is the study measuring?
Primary Outcome Measures
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
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Concentration of creatine kinase will be measured in plasma
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At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
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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
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Concentration of uric acid will be measured in plasma
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At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
|
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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
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Concentration of protein carbonyls will be measured in red blood cells
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At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
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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
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Total antioxidant capacity will be measured in plasma
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At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
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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
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Concentration of reduced glutathione will be measured in in red blood cells
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At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
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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
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Concentration of oxidized glutathione will be measured in red blood cells
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At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
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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
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Concentration of malondialdehyde will be measured in serum
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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
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Catalase activity will be measured in red blood cells
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At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
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Change in protein carbonyls in muscle
Time Frame: At baseline, 24h post-Match 1 and 24h post-Match 2
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Concentration of protein carbonyls will be measured in muscle
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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
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Phosphorylation levels of Akt, mammalian target of rapamycin (mTOR) and p70S6K will be measure using western blotting.
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At baseline, 24h post-Match 1 and 24h post-Match 2
|
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Change in proteasome activities in muscle
Time Frame: At baseline, 24h post-Match 1 and 24h post-Match 2
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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.
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At baseline, 24h post-Match 1 and 24h post-Match 2
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Change in satellite cells in muscle
Time Frame: At baseline, 24h post-Match 1 and 24h post-Match 2
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Pax7, Myf5, MyoD and Myogenin will be measured in order to quantify quiescent, activated, proliferated-differentiated and fused satellite cells respectively.
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At baseline, 24h post-Match 1 and 24h post-Match 2
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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
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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.
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At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
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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
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Countermovement jump will be assessed on a contact platform
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At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
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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
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Isokinetic strength will be assessed on an isokinetic dynamometer for both knee extensors and knee flexors at 120 and 180 degrees.
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At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
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Change in match activity
Time Frame: During Match 1 and Match 2
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Match activity will be continuously recorded during both matches using GPS technology.
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During Match 1 and Match 2
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Change in heart rate
Time Frame: During Match 1 and Match 2
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Heart rate will be continuously recorded during both matches using the Team Polar system.
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During Match 1 and Match 2
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dietary intake
Time Frame: Over a 7-day period at baseline.
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Dietary intake will be assessed using 7-day diet recalls.
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Over a 7-day period at baseline.
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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
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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).
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At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
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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.
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White blood cell count will be measured using an automatic blood analyzer.
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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)
May 1, 2016
Primary Completion (Actual)
June 30, 2016
Study Completion (Actual)
September 15, 2016
Study Registration Dates
First Submitted
November 15, 2017
First Submitted That Met QC Criteria
November 17, 2017
First Posted (Actual)
November 20, 2017
Study Record Updates
Last Update Posted (Actual)
January 30, 2018
Last Update Submitted That Met QC Criteria
January 26, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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