Clinical trial NCT02816411: Protein Supplementation and Skeletal Muscle Healing Process
Official title: Effects of Protein Supplementation on Skeletal Muscle Regeneration and Healing Process Following Exercise-induced Aseptic Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skeletal Muscle Damage
Exercise-induced Aseptic Inflammation
Skeletal Muscle Performance
Intracellular Signaling in Skeletal Muscle
Proteasome Activation
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In this study the investigators utilized protein supplementation over an 8-day period following eccentric exercise-induced muscle damage in order to test the initial hypotheses : i) protein supplementation after exercise-induced muscle injury affects exercise-induced aseptic inflammation and muscle performance.

Detailed description: The objective was to examine weather protein supplementation is able to affect the inflammatory response as well as recovery of muscle performance following an intense eccentric exercise protocol. In a double-blind, counterbalanced design, 14 men received either Placebo (PLA) or milk protein isolate (PRO) for 8 consecutive days following a single bout of exercise (300 eccentric contractions at 30 deg/sec). In both conditions, performance was assessed at baseline, immediately post-exercise, 2h post-exercise and daily for 8 consecutive days. Blood samples were collected at baseline, 2h post-exercise and daily for the remaining 8 days. Muscle biopsies from vastus lateralis were collected at baseline as well as at day 2 and day 8 of the post-exercise period.

Eligibility criteria: Inclusion Criteria:

* a) recreationally trained as indicated by the maximal oxygen consumption levels (VO2max \> 45 ml/kg/min), b) engaged in systematic exercise at least three times per week for \> 12 months, c) non-smokers, d) abstained from any vigorous physical activity during the study, e) abstained from consumption of caffeine, alcohol, performance-enhancing or antioxidant supplements, and medications during the study.

Exclusion Criteria:

* a) a recent febrile illness, b) history of muscle lesion, c) lower limb trauma

Primary outcomes:
measure: Change in reduced glutathione in blood
timeFrame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
measure: Change in protein carbonyls in serum
timeFrame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
measure: Change in protein carbonyls in muscle
timeFrame: 1h before exercise, 2 days post-exercise, 8 days post-exercise
measure: Change in thiobarbituric acid and reactive substances in serum
timeFrame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
measure: Change in oxidized glutathione in blood
timeFrame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
measure: Change in total antioxidant capacity in serum
timeFrame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
measure: Change in catalase activity in serum
timeFrame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
measure: Change in creatine kinase activity in plasma
timeFrame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
measure: Change in C-reactive protein in plasma
timeFrame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
measure: Change in white blood cell count in blood
timeFrame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
measure: Changes in volume and morphological complexity of immune cells
timeFrame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
measure: Change in neutrophil count in blood
timeFrame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
measure: Change in glucose concentration in blood
timeFrame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
measure: Change in insulin concentration in blood
timeFrame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
measure: Change in testosterone concentration in plasma
timeFrame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
measure: Change in cytokine concentration in plasma
timeFrame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
measure: Change in adhesion molecule concentration in blood
timeFrame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
measure: Change in intracellular signalling proteins in muscle
timeFrame: 1h before exercise, 2 days post-exercise, 8 days post-exercise
measure: Change in proteasome activities in muscle
timeFrame: 1h before exercise, 2 days post-exercise, 8 days post-exercise
measure: Change in protein expression level of proteasome subunits
timeFrame: 1h before exercise, 2 days post-exercise, 8 days post-exercise
Secondary outcomes:
measure: Change in muscle function of knee extensor and flexor muscle
timeFrame: 1h before exercise, 5 min post-exercise, 2h post-exercise, daily for 8 days post-exercise
measure: Body composition
timeFrame: One day before exercise
measure: Maximal aerobic capacity
timeFrame: One day before exercise
measure: Change in dietary intake profile
timeFrame: 1h before exercise, daily for 8 days post-exercise
Other outcomes:
Locations:
city: Karies, Trikala
country: Greece
facility: Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly
Study officials:
affiliation: UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES
name: IOANNIS G. FATOUROS, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: