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Trial record 83 of 215 for:    Inflammatory Myopathies

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

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ClinicalTrials.gov Identifier: NCT03348267
Recruitment Status : Completed
First Posted : November 20, 2017
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Athanasios Z. Jamurtas, University of Thessaly

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.

Condition or disease Intervention/treatment Phase
Skeletal Muscle Damage Muscle Inflammation Muscle Recovery Soccer Performance Dietary Supplement: Milk protein isolate Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Milk Protein Supplementation on Muscle Recovery and Football-specific Performance During an In-season Microcycle With Two Matches
Actual Study Start Date : May 1, 2016
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : September 15, 2016


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.
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.




Primary Outcome Measures :
  1. 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

  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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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

  15. 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.

  16. Change in match activity [ Time Frame: During Match 1 and Match 2 ]
    Match activity will be continuously recorded during both matches using GPS technology.

  17. 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.


Secondary Outcome Measures :
  1. 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).

  2. Dietary intake [ Time Frame: Over a 7-day period at baseline. ]
    Dietary intake will be assessed using 7-day diet recalls.

  3. 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.



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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348267


Locations
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Greece
Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly
Tríkala, Greece, 42100
Sponsors and Collaborators
University of Thessaly
Investigators
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Principal Investigator: ATHANASIOS POULIOS, PhDc UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES

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Responsible Party: Athanasios Z. Jamurtas, Professor, University of Thessaly
ClinicalTrials.gov Identifier: NCT03348267     History of Changes
Other Study ID Numbers: PROTEIN-FOOTBALL RECOVERY-UTH
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Myositis
Muscular Diseases
Inflammation
Pathologic Processes
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action