Protein Supplementation and Skeletal Muscle Healing Process

NCT02816411 | Completed

• 1 other identifier: PROTEIN-MUSCLEINJURY-2014
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Skeletal Muscle Damage; Exercise-induced Aseptic Inflammation; Skeletal Muscle Performance; Intracellular Signaling in Skeletal Muscle; Proteasome Activation

Outcome Measures

Primary Outcomes (20)

• Change in reduced glutathione in blood

  Concentration of reduced glutathione in red blood cells

  1h before exercise, 2h post-exercise, daily for 8 days post-exercise

• Change in protein carbonyls in serum

  Concentration of protein carbonyls

  1h before exercise, 2h post-exercise, daily for 8 days post-exercise

• Change in protein carbonyls in muscle

  Protein carbonyl concentration in quadriceps skeletal muscle group

  1h before exercise, 2 days post-exercise, 8 days post-exercise

• Change in thiobarbituric acid and reactive substances in serum

  Thiobarbituric acid reactive substances concentration in serum

  1h before exercise, 2h post-exercise, daily for 8 days post-exercise

• Change in oxidized glutathione in blood

  Concentration of oxidized glutathione in red blood cells

  1h before exercise, 2h post-exercise, daily for 8 days post-exercise

• Change in total antioxidant capacity in serum

  Total antioxidant capacity in serum

  1h before exercise, 2h post-exercise, daily for 8 days post-exercise

• Change in catalase activity in serum

  Catalase activity in serum

  1h before exercise, 2h post-exercise, daily for 8 days post-exercise

• Change in creatine kinase activity in plasma

  1h before exercise, 2h post-exercise, daily for 8 days post-exercise

• Change in C-reactive protein in plasma

  1h before exercise, 2h post-exercise, daily for 8 days post-exercise

• Change in white blood cell count in blood

  1h before exercise, 2h post-exercise, daily for 8 days post-exercise

• Changes in volume and morphological complexity of immune cells

  1h before exercise, 2h post-exercise, daily for 8 days post-exercise

• Change in neutrophil count in blood

  1h before exercise, 2h post-exercise, daily for 8 days post-exercise

• Change in glucose concentration in blood

  1h before exercise, 2h post-exercise, daily for 8 days post-exercise

• Change in insulin concentration in blood

  1h before exercise, 2h post-exercise, daily for 8 days post-exercise

• Change in testosterone concentration in plasma

  1h before exercise, 2h post-exercise, daily for 8 days post-exercise

• Change in cytokine concentration in plasma

  Measurement of IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-α

  1h before exercise, 2h post-exercise, daily for 8 days post-exercise

• Change in adhesion molecule concentration in blood

  1h before exercise, 2h post-exercise, daily for 8 days post-exercise

• Change in intracellular signalling proteins in muscle

  Measurement of phosphorylation levels of mammalian target of rapamycin (mTOR), ribosomal protein S6 (rpS6) and nuclear factor kB (NFkB), and protein expression levels of forkhead box protein O1 (FOXO1), HSP70, and parkin.

  1h before exercise, 2 days post-exercise, 8 days post-exercise

• Change in proteasome activities in muscle

  Measurement of LLVY, LSTR and LLE

  1h before exercise, 2 days post-exercise, 8 days post-exercise

• Change in protein expression level of proteasome subunits

  Measurement of B1i, B2i, B5i, B5, B1, B2 and α7

  1h before exercise, 2 days post-exercise, 8 days post-exercise

Secondary Outcomes (4)

• Change in muscle function of knee extensor and flexor muscle

  1h before exercise, 5 min post-exercise, 2h post-exercise, daily for 8 days post-exercise

• Body composition

  One day before exercise

• Maximal aerobic capacity

  One day before exercise

• Change in dietary intake profile

  1h before exercise, daily for 8 days post-exercise

Study Arms (2)

Protein

EXPERIMENTAL

Milk protein isolate supplementation: orally, 20g of protein immediately post-exercise and then 20g every 3h on 3 occasions (+3, +6, +9), on the exercise day. The remaining 8 days, 20g daily with breakfast.

Dietary Supplement: Milk protein isolate

Placebo

ACTIVE COMPARATOR

Placebo administration: orally 500 ml, immediately post-exercise as well as at +3, +6 and +9 hours, on the exercise day. The remaining 8 days, 500 ml daily with breakfast.

Dietary Supplement: Placebo

Interventions

Milk protein isolate DIETARY_SUPPLEMENT

Milk protein isolate in a powder form consisted of 80% casein and 20% whey protein. 20g were diluted into 500 ml water. Placebo consisted of 365 ml water, 125 ml sugar-free cordial and 2g of low-calorie glucose/dextrose powder.

Protein

Placebo DIETARY_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

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

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

Karies, Trikala, 42100, Greece

Location

Study Officials

• IOANNIS G. FATOUROS, Ph.D.

  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: Associate Professor

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: June 28, 2016
• Study Start: May 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 4, 2016

Record last verified: 2016-07

Locations

GR (1)