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Completed

NCT Number: NCT02816411

Protein Supplementation and Skeletal Muscle Healing Process

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.

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Key information

Conditions

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

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Karies, Trikala, 42100, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in reduced glutathione in blood

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

    Concentration of reduced glutathione in red blood cells

  2. Change in protein carbonyls in serum

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

    Concentration of protein carbonyls

  3. Change in protein carbonyls in muscle

    Time frame: 1h before exercise, 2 days post-exercise, 8 days post-exercise

    Protein carbonyl concentration in quadriceps skeletal muscle group

  4. Change in thiobarbituric acid and reactive substances in serum

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

    Thiobarbituric acid reactive substances concentration in serum

  5. Change in oxidized glutathione in blood

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

    Concentration of oxidized glutathione in red blood cells

  6. Change in total antioxidant capacity in serum

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

    Total antioxidant capacity in serum

  7. Change in catalase activity in serum

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

    Catalase activity in serum

  8. Change in creatine kinase activity in plasma

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

  9. Change in C-reactive protein in plasma

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

  10. Change in white blood cell count in blood

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

  11. Changes in volume and morphological complexity of immune cells

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

  12. Change in neutrophil count in blood

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

  13. Change in glucose concentration in blood

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

  14. Change in insulin concentration in blood

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

  15. Change in testosterone concentration in plasma

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

  16. Change in cytokine concentration in plasma

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

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

  17. Change in adhesion molecule concentration in blood

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

  18. Change in intracellular signalling proteins in muscle

    Time frame: 1h before exercise, 2 days post-exercise, 8 days post-exercise

    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.

  19. Change in proteasome activities in muscle

    Time frame: 1h before exercise, 2 days post-exercise, 8 days post-exercise

    Measurement of LLVY, LSTR and LLE

  20. Change in protein expression level of proteasome subunits

    Time frame: 1h before exercise, 2 days post-exercise, 8 days post-exercise

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

Secondary outcomes

  1. Change in muscle function of knee extensor and flexor muscle

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

    Assessment of muscle peak and mean torque of knee extensors and flexors on an isokinetic dynamometer at 0, 90 and 180 degrees/sec

  2. Body composition

    Time frame: One day before exercise

    Assessment of percent (%) body mass

  3. Maximal aerobic capacity

    Time frame: One day before exercise

    Assessment of maximal oxygen consumption

  4. Change in dietary intake profile

    Time frame: 1h before exercise, daily for 8 days post-exercise

    Assessment of dietary intake with emphasis on protein consumption

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 28, 2016
Registry last updated
Oct 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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