- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04841772
Exploring Muscle Breakdown During Exercise Recovery (EMBER)
March 21, 2023 updated by: University of Exeter
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kiera Wilkinson
- Phone Number: 01392 725906
- Email: kw509@exeter.ac.uk
Study Contact Backup
- Name: George Pavis
- Email: G.Pavis@exeter.ac.uk
Study Locations
-
-
Devon
-
Exeter, Devon, United Kingdom, EX1 2LU
- University of Exeter
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Recreationally active
- 18-40 years of age
Exclusion Criteria:
- 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
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Post exercise placebo supplement (32g maltodextrin)
|
Active Comparator: Vegan Protein
|
Post exercise protein supplement (26g pea protein)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle protein breakdown rate
Time Frame: 1hour
|
Muscle protein breakdown rate (FBR, measured in %/h) 24hours post eccentric exercise.
|
1hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle protein synthesis rate
Time Frame: 3hours
|
Muscle protein synthesis rate (FSR, measured in %/h) 24hours post eccentric exercise.
|
3hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 8, 2021
Primary Completion (Actual)
December 1, 2022
Study Completion (Actual)
December 1, 2022
Study Registration Dates
First Submitted
April 9, 2021
First Submitted That Met QC Criteria
April 9, 2021
First Posted (Actual)
April 12, 2021
Study Record Updates
Last Update Posted (Actual)
March 23, 2023
Last Update Submitted That Met QC Criteria
March 21, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 210203-B-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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