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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03348267
Other study ID # PROTEIN-FOOTBALL RECOVERY-UTH
Secondary ID
Status Completed
Phase N/A
First received November 15, 2017
Last updated January 26, 2018
Start date May 1, 2016
Est. completion date September 15, 2016

Study information

Verified date January 2018
Source University of Thessaly
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date September 15, 2016
Est. primary completion date June 30, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 25 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Greece Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly Tríkala

Sponsors (1)

Lead Sponsor Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary Change in match activity Match activity will be continuously recorded during both matches using GPS technology. During Match 1 and Match 2
Primary 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 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). At baseline, at 24h, 48h and 72h post-Match 1 as well as at 24h, 48h and 72h post-Match 2
Secondary Dietary intake Dietary intake will be assessed using 7-day diet recalls. Over a 7-day period at baseline.
Secondary Change in white blood cell count. 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.
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