NCT03348267

Brief 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. 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.

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 May 2016

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

2 months

First QC Date

November 15, 2017

Last Update Submit

January 26, 2018

Conditions

Outcome Measures

Primary Outcomes (17)

  • Change in creatine kinase in plasma

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    Match activity will be continuously recorded during both matches using GPS technology.

    During Match 1 and Match 2

  • Change in heart rate

    Heart rate will be continuously recorded during both matches using the Team Polar system.

    During Match 1 and Match 2

Secondary Outcomes (3)

  • Change in delayed onset of muscle soreness

    At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2

  • Dietary intake

    Over a 7-day period at baseline.

  • Change in white blood cell count.

    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.

Study Arms (2)

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.

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.

Dietary Supplement: Placebo

Interventions

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

Protein
PlaceboDIETARY_SUPPLEMENT

500 mL drink that contained water (375 mL), sugar-free cordial (125 mL) and 2 g of low-calorie glucose/dextrose powder.

Placebo

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly

Trikala, 42100, Greece

Location

MeSH Terms

Conditions

Myositis, Inclusion Body

Condition Hierarchy (Ancestors)

MyositisMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • ATHANASIOS POULIOS, PhDc

    UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES

    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

November 15, 2017

First Posted

November 20, 2017

Study Start

May 1, 2016

Primary Completion

June 30, 2016

Study Completion

September 15, 2016

Last Updated

January 30, 2018

Record last verified: 2018-01

Locations