Muscle DamageEMBERNCT04841772
Exploring Muscle Breakdown During Exercise Recovery
A study testing Recover Vegan Protein Supplement in people with Muscle Damage and Healthy, run by University of Exeter at 1 site in United Kingdom.
Trial summary
This study will allow researchers to explore how muscle responds to heavy exercise. The researchers will characterise rates of muscle protein breakdown and synthesis 24hours after heavy exercise with a post exercise protein polyphenol or placebo supplementation. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Damage, Healthy
- What is being tested?
- Recover Vegan Protein Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Apr 2021to 1 Dec 2022
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recreationally active
- 18-40 years of age
Who cannot join
- Regular and structured involvement in resistance training
- Inactive participants
- Habitual dietary protein intake <0.8g/kg bw/day and >2.0g/kg bw/day
- Regular use of nutritional supplements known to suppress inflammation or modulate protein metabolism Any diagnosed metabolic conditions (diabetes), cardiovascular disease or hypertension
- Current musculoskeletal injury
- Chronic use of anti-inflammatory medicines
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- Any known disorders in muscle metabolism
- Individuals with an allergy to egg, fish, wheat or soy ingredients as the product is manufactured in a facility that contains these ingredients
- Allergy to lidocaine
- Having received or ingested a stable isotope tracer containing 15N in the past
- A personal or family history of epilepsy, seizures or schizophrenia
- Stomach bleeding or stomach ulcer
- Kidney failure
- Liver problems, such as fibrosis, cirrhosis or failure
- Crohns disease or ulcerative colitis
- Chickenpox or shingles
- Pregnant or trying to get pregnant
- Any diagnosed cardiovascular disease (e.g. deep vein thrombosis) or hypertension.
- Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes)
- Recent (within the last 6 months) or current musculoskeletal injury (leg fracture)
Trial locations and contacts
1 site in 1 country.
About this study
This study will allow researchers to explore how muscle responds to heavy exercise. The researchers will characterise rates of muscle protein breakdown and synthesis 24hours after heavy exercise with a post exercise protein polyphenol or placebo supplementation. This will inform strategies to help people recover from heavy exercise.
Read the detailed description
It is well known that resistance exercise increases rates of muscle protein synthesis and breakdown, with the rise in synthesis greater in magnitude and duration. The time course of rates of muscle protein synthesis increase dramatically 24-72h following eccentric exercise, even in a non-exercised control leg. This data is consistent with a much larger increase in muscle protein breakdown than previously thought. However, the response of muscle protein breakdown following damaging eccentric exercise, and its relationship with muscle protein synthesis, has not yet been elucidated. Moreover, it is unclear whether a protein and polyphenol nutritional intervention influence rates of muscle protein breakdown to accelerate recovery. This study will allow researchers to test the hypothesis that eccentric exercise increases rates of muscle protein breakdown independently of muscle contraction per se. If this hypothesis is supported, it will highlight that recovery strategies from muscle damage should also target supporting muscle protein breakdown.
- Conditions
- Muscle Damage, Healthy
- Being tested
- Recover Vegan Protein Supplement, Placebo
- Keywords
- Skeletal muscle, Postabsorptive, Muscle protein breakdown, Muscle protein synthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recover Vegan Protein SupplementDietary supplement
Post exercise protein supplement (26g pea protein)
PlaceboDietary supplement
Post exercise placebo supplement (32g maltodextrin)
| Study group | Role | What they receive |
|---|---|---|
| Vegan Protein | Active comparator | Not described Receives: Dietary Supplement: Recover Vegan Protein Supplement |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein breakdown rate
Muscle protein breakdown rate (FBR, measured in %/h) 24hours post eccentric exercise.
Measured: 1hour
Secondary outcomes (1)
Muscle protein synthesis rate
Muscle protein synthesis rate (FSR, measured in %/h) 24hours post eccentric exercise.
Measured: 3hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start8 Apr 2021
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle DamageStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- Beachbody
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841772
- Sponsor's protocol ID
- 210203-B-01
- Acronym
- EMBER
- Status last verified
- Mar 2023
- First submitted
- 9 Apr 2021
- Last updated
- 23 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Muscle Breakdown During Exercise Recovery
- ClinicalTrials.gov ID
- NCT04841772
- Acronym / sponsor ID
- EMBER / 210203-B-01
- Conditions
- Muscle Damage, Healthy
- Keywords
- Skeletal muscle, Postabsorptive, Muscle protein breakdown, Muscle protein synthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- Beachbody
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 12 Apr 2021 (actual)
- 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.
This study will allow researchers to explore how muscle responds to heavy exercise. The researchers will characterise rates of muscle protein breakdown and synthesis 24hours after heavy exercise with a post exercise protein polyphenol or placebo supplementation. This will inform strategies to help people recover from heavy exercise.
Detailed description
It is well known that resistance exercise increases rates of muscle protein synthesis and breakdown, with the rise in synthesis greater in magnitude and duration. The time course of rates of muscle protein synthesis increase dramatically 24-72h following eccentric exercise, even in a non-exercised control leg. This data is consistent with a much larger increase in muscle protein breakdown than previously thought. However, the response of muscle protein breakdown following damaging eccentric exercise, and its relationship with muscle protein synthesis, has not yet been elucidated. Moreover, it is unclear whether a protein and polyphenol nutritional intervention influence rates of muscle protein breakdown to accelerate recovery. This study will allow researchers to test the hypothesis that eccentric exercise increases rates of muscle protein breakdown independently of muscle contraction per se. If this hypothesis is supported, it will highlight that recovery strategies from muscle damage should also target supporting muscle protein breakdown.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vegan Protein | Active comparator | Dietary Supplement: Recover Vegan Protein Supplement |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Recreationally active
- 18-40 years of age
Key exclusion criteria (20 listed)
- Regular and structured involvement in resistance training
- Inactive participants
- Habitual dietary protein intake <0.8g/kg bw/day and >2.0g/kg bw/day
- Regular use of nutritional supplements known to suppress inflammation or modulate protein metabolism Any diagnosed metabolic conditions (diabetes), cardiovascular disease or hypertension
- Current musculoskeletal injury
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 |
|---|---|---|
| Recover Vegan Protein SupplementPost exercise protein supplement (26g pea protein) | Dietary supplement | Vegan Protein |
| PlaceboPost exercise placebo supplement (32g maltodextrin) | Dietary supplement | Placebo |
Primary outcome
Muscle protein breakdown rate
Time frame: 1hour
Muscle protein breakdown rate (FBR, measured in %/h) 24hours post eccentric exercise.
1 secondary outcome
Muscle protein synthesis rate
Time frame: 3hours
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 23 Mar 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recover Vegan Protein Supplement in people with Muscle Damage and Healthy, run by University of Exeter at 1 site in United Kingdom.
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 2 inclusion and 20 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 23 Mar 2023. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Muscle protein breakdown rate (time frame: 1hour). 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 23 Mar 2023.