Skeletal Muscle DamageNCT02816411
Protein Supplementation and Skeletal Muscle Healing Process
A study testing Milk protein isolate in people with Skeletal Muscle Damage and Exercise-induced Aseptic Inflammation, run by University of Thessaly at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Skeletal Muscle Damage, Exercise-induced Aseptic Inflammation, Skeletal Muscle Performance
- What is being tested?
- Milk protein isolate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteGreece
- Study dates
- May 2014to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- a) a recent febrile illness, b) history of muscle lesion, c) lower limb trauma
Trial locations and contacts
1 site in 1 country.
Greece1 site
Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly
Karies, Trikala, 42100
About this study
Official title: Effects of Protein Supplementation on Skeletal Muscle Regeneration and Healing Process Following Exercise-induced Aseptic Injury
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.
Read the 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.
- Conditions
- Skeletal Muscle Damage, Exercise-induced Aseptic Inflammation, Skeletal Muscle Performance, Intracellular Signaling in Skeletal Muscle, Proteasome Activation
- Being tested
- Milk protein isolate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk protein isolateDietary 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.
PlaceboDietary supplement
500 mL drink that contained water (375 mL), sugar-free cordial (125 mL) and 2 g of low-calorie glucose/dextrose powder.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in reduced glutathione in blood
Concentration of reduced glutathione in red blood cells
Measured: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
Change in protein carbonyls in serum
Concentration of protein carbonyls
Measured: 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
Measured: 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
Measured: 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
Measured: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
Change in total antioxidant capacity in serum
Total antioxidant capacity in serum
Measured: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
Change in catalase activity in serum
Catalase activity in serum
Measured: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
Change in creatine kinase activity in plasma
Measured: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
Change in C-reactive protein in plasma
Measured: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
Change in white blood cell count in blood
Measured: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
Changes in volume and morphological complexity of immune cells
Measured: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
Change in neutrophil count in blood
Measured: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
Change in glucose concentration in blood
Measured: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
Change in insulin concentration in blood
Measured: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
Change in testosterone concentration in plasma
Measured: 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
Measured: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
Change in adhesion molecule concentration in blood
Measured: 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.
Measured: 1h before exercise, 2 days post-exercise, 8 days post-exercise
Change in proteasome activities in muscle
Measurement of LLVY, LSTR and LLE
Measured: 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
Measured: 1h before exercise, 2 days post-exercise, 8 days post-exercise
Secondary outcomes (4)
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
Measured: 1h before exercise, 5 min post-exercise, 2h post-exercise, daily for 8 days post-exercise
Body composition
Assessment of percent (%) body mass
Measured: One day before exercise
Maximal aerobic capacity
Assessment of maximal oxygen consumption
Measured: One day before exercise
Change in dietary intake profile
Assessment of dietary intake with emphasis on protein consumption
Measured: 1h before exercise, daily for 8 days post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startMay 2014
- Primary completionFeb 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal Muscle DamageStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ioannis G. Fatouros, University of Thessaly
- Investigators
- IOANNIS G. FATOUROS, Ph.D., Principal investigator, UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816411
- Sponsor's protocol ID
- PROTEIN-MUSCLEINJURY-2014
- Status last verified
- Jul 2016
- First submitted
- 24 Jun 2016
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Protein Supplementation on Skeletal Muscle Regeneration and Healing Process Following Exercise-induced Aseptic Injury
- ClinicalTrials.gov ID
- NCT02816411
- Acronym / sponsor ID
- PROTEIN-MUSCLEINJURY-2014
- Conditions
- Skeletal Muscle Damage, Exercise-induced Aseptic Inflammation, Skeletal Muscle Performance, Intracellular Signaling in Skeletal Muscle, Proteasome Activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein | Experimental | Dietary Supplement: Milk protein isolateMilk 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. |
| Placebo | Active comparator | Dietary Supplement: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- a) a recent febrile illness, b) history of muscle lesion, c) lower limb trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Milk protein isolateMilk 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. | Dietary supplement | Protein |
| Placebo500 mL drink that contained water (375 mL), sugar-free cordial (125 mL) and 2 g of low-calorie glucose/dextrose powder. | Dietary supplement | Placebo |
Primary outcome
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
Change in protein carbonyls in serum
Time frame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
Concentration of protein carbonyls
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
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
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
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
Change in catalase activity in serum
Time frame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
Catalase activity in serum
Change in creatine kinase activity in plasma
Time frame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
Change in C-reactive protein in plasma
Time frame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
Change in white blood cell count in blood
Time frame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
Changes in volume and morphological complexity of immune cells
Time frame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
Change in neutrophil count in blood
Time frame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
Change in glucose concentration in blood
Time frame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
Change in insulin concentration in blood
Time frame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
Change in testosterone concentration in plasma
Time frame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
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
Change in adhesion molecule concentration in blood
Time frame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise
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.
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
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
4 secondary outcomes
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
Body composition
Time frame: One day before exercise
Maximal aerobic capacity
Time frame: One day before exercise
Change in dietary intake profile
Time frame: 1h before exercise, daily for 8 days post-exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
IOANNIS G. FATOUROS, Ph.D. principal investigator
UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk protein isolate in people with Skeletal Muscle Damage and Exercise-induced Aseptic Inflammation, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in reduced glutathione in blood (time frame: 1h before exercise, 2h post-exercise, daily for 8 days post-exercise). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2016.