Skeletal Muscle DamagePRO-FOOTBALLNCT03348267
Protein Supplementation and Muscle Recovery in Football
A study testing Milk protein isolate in people with Skeletal Muscle Damage and Muscle Inflammation, run by University of Thessaly at 1 site in Greece.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Skeletal Muscle Damage, Muscle Inflammation, Muscle Recovery
- What is being tested?
- Milk protein isolate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- 1 May 2016to 15 Sep 2016
- 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 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Greece1 site
Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly
Trikala, 42100
About this study
Official title: 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.
Read the 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.
- Being tested
- Milk protein isolate, Placebo
- Medical subject headings
- Myositis, Inclusion Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk protein isolateDietary supplement
Milk protein isolate in a powder form consisted of 80% casein and 20% whey protein. 20g were diluted into 500 ml water
PlaceboDietary supplement
500 mL drink that contained water (375 mL), sugar-free cordial (125 mL) and 2 g of low-calorie glucose/dextrose powder.
| Study group | Role | What they receive |
|---|---|---|
| Protein | Experimental | 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. Receives: Dietary Supplement: Milk protein isolate |
| Placebo | Active comparator | 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in creatine kinase in plasma
Concentration of creatine kinase will be measured in plasma
Measured: 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
Concentration of uric acid will be measured in plasma
Measured: 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
Concentration of protein carbonyls will be measured in red blood cells
Measured: 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
Total antioxidant capacity will be measured in plasma
Measured: 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
Concentration of reduced glutathione will be measured in in red blood cells
Measured: 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
Concentration of oxidized glutathione will be measured in red blood cells
Measured: 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
Concentration of malondialdehyde will be measured in serum
Measured: 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
Catalase activity will be measured in red blood cells
Measured: 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
Concentration of protein carbonyls will be measured in muscle
Measured: At baseline, 24h post-Match 1 and 24h post-Match 2
Change in intracellular signaling proteins in muscle
Phosphorylation levels of Akt, mammalian target of rapamycin (mTOR) and p70S6K will be measure using western blotting.
Measured: At baseline, 24h post-Match 1 and 24h post-Match 2
Change in proteasome activities in muscle
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.
Measured: At baseline, 24h post-Match 1 and 24h post-Match 2
Change in satellite cells in muscle
Pax7, Myf5, MyoD and Myogenin will be measured in order to quantify quiescent, activated, proliferated-differentiated and fused satellite cells respectively.
Measured: At baseline, 24h post-Match 1 and 24h post-Match 2
Change in repeated Sprint Ability
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.
Measured: 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
Countermovement jump will be assessed on a contact platform
Measured: 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
Isokinetic strength will be assessed on an isokinetic dynamometer for both knee extensors and knee flexors at 120 and 180 degrees.
Measured: 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
Match activity will be continuously recorded during both matches using GPS technology.
Measured: During Match 1 and Match 2
Change in heart rate
Heart rate will be continuously recorded during both matches using the Team Polar system.
Measured: During Match 1 and Match 2
Secondary outcomes (3)
Change in delayed onset of muscle soreness
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).
Measured: At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
Dietary intake
Dietary intake will be assessed using 7-day diet recalls.
Measured: Over a 7-day period at baseline.
Change in white blood cell count.
White blood cell count will be measured using an automatic blood analyzer.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start1 May 2016
- Primary completion30 Jun 2016
- Study completion15 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal Muscle DamageStudies 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, Athanasios Z. Jamurtas, University of Thessaly
- Investigators
- ATHANASIOS POULIOS, PhDc, Principal investigator, UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348267
- Sponsor's protocol ID
- PROTEIN-FOOTBALL RECOVERY-UTH
- Acronym
- PRO-FOOTBALL
- Status last verified
- Jan 2018
- First submitted
- 15 Nov 2017
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Milk Protein Supplementation on Muscle Recovery and Football-specific Performance During an In-season Microcycle With Two Matches
- ClinicalTrials.gov ID
- NCT03348267
- Acronym / sponsor ID
- PRO-FOOTBALL / PROTEIN-FOOTBALL RECOVERY-UTH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 15 Sep 2016 (actual)
- First posted
- 20 Nov 2017 (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.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein | Experimental | Dietary Supplement: Milk protein isolateOn 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. |
| Placebo | Active comparator | Dietary Supplement: PlaceboOn 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Milk protein isolateMilk protein isolate in a powder form consisted of 80% casein and 20% whey protein. 20g were diluted into 500 ml water | Dietary supplement | Protein |
| Placebo500 mL drink that contained water (375 mL), sugar-free cordial (125 mL) and 2 g of low-calorie glucose/dextrose powder. | Dietary supplement | Placebo |
Primary outcome
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
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
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
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
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
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
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
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
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
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.
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.
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.
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.
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
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.
Change in match activity
Time frame: During Match 1 and Match 2
Match activity will be continuously recorded during both matches using GPS technology.
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.
3 secondary outcomes
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
Dietary intake
Time frame: Over a 7-day period at baseline.
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.
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 30 Jan 2018.
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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.
ATHANASIOS POULIOS, PhDc principal investigator
UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk protein isolate in people with Skeletal Muscle Damage and Muscle Inflammation, 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 1 inclusion and 1 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 30 Jan 2018. 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?
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). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2018.