Protein Supplementation and Skeletal Muscle Healing Process

Skeletal Muscle Damage Clinical Trial

Official title:

Effects of Protein Supplementation on Skeletal Muscle Regeneration and Healing Process Following Exercise-induced Aseptic Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02816411
• Other study ID #: PROTEIN-MUSCLEINJURY-2014
• Status: Completed
• Phase: N/A
• First received: June 24, 2016
• Last updated: October 3, 2016
• Start date: May 2014
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: University of Thessaly
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

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

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 consisted of 365 ml water, 125 ml sugar-free cordial and 2g of low-calorie glucose/dextrose powder.
• 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	Karies, Trikala

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 reduced glutathione in blood	Concentration of reduced glutathione in red blood cells	1h before exercise, 2h post-exercise, daily for 8 days post-exercise	No
Primary	Change in protein carbonyls in serum	Concentration of protein carbonyls	1h before exercise, 2h post-exercise, daily for 8 days post-exercise	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Change in total antioxidant capacity in serum	Total antioxidant capacity in serum	1h before exercise, 2h post-exercise, daily for 8 days post-exercise	No
Primary	Change in catalase activity in serum	Catalase activity in serum	1h before exercise, 2h post-exercise, daily for 8 days post-exercise	No
Primary	Change in creatine kinase activity in plasma		1h before exercise, 2h post-exercise, daily for 8 days post-exercise	No
Primary	Change in C-reactive protein in plasma		1h before exercise, 2h post-exercise, daily for 8 days post-exercise	No
Primary	Change in white blood cell count in blood		1h before exercise, 2h post-exercise, daily for 8 days post-exercise	No
Primary	Changes in volume and morphological complexity of immune cells		1h before exercise, 2h post-exercise, daily for 8 days post-exercise	No
Primary	Change in neutrophil count in blood		1h before exercise, 2h post-exercise, daily for 8 days post-exercise	No
Primary	Change in glucose concentration in blood		1h before exercise, 2h post-exercise, daily for 8 days post-exercise	No
Primary	Change in insulin concentration in blood		1h before exercise, 2h post-exercise, daily for 8 days post-exercise	No
Primary	Change in testosterone concentration in plasma		1h before exercise, 2h post-exercise, daily for 8 days post-exercise	No
Primary	Change in cytokine concentration in plasma	Measurement of IL-1ß, IL-4, IL-6, IL-8, IL-10, TNF-a	1h before exercise, 2h post-exercise, daily for 8 days post-exercise	No
Primary	Change in adhesion molecule concentration in blood		1h before exercise, 2h post-exercise, daily for 8 days post-exercise	No
Primary	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	No
Primary	Change in proteasome activities in muscle	Measurement of LLVY, LSTR and LLE	1h before exercise, 2 days post-exercise, 8 days post-exercise	No
Primary	Change in protein expression level of proteasome subunits	Measurement of B1i, B2i, B5i, B5, B1, B2 and a7	1h before exercise, 2 days post-exercise, 8 days post-exercise	No
Secondary	Change in muscle function of knee extensor and flexor muscle	Assessment of muscle peak and mean torque of knee extensors and flexors on an isokinetic dynamometer at 0, 90 and 180 degrees/sec	1h before exercise, 5 min post-exercise, 2h post-exercise, daily for 8 days post-exercise	No
Secondary	Body composition	Assessment of percent (%) body mass	One day before exercise	No
Secondary	Maximal aerobic capacity	Assessment of maximal oxygen consumption	One day before exercise	No
Secondary	Change in dietary intake profile	Assessment of dietary intake with emphasis on protein consumption	1h before exercise, daily for 8 days post-exercise	No