Muscle Protein SynthesisBPMNCT04894747
Mycoprotein and Pea Protein Blend and Muscle Protein Synthetic Response
A study testing Bolus ingestion of protein in people with Muscle Protein Synthesis, run by University of Exeter at 1 site in United Kingdom.
Trial summary
Dietary protein is vital for the preservation of health and optimal adaptation to training. Plant proteins are considered inferior to animal proteins with respect to their ability to stimulate an acute muscle building response and therefore support long-term muscle reconditioning. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Protein Synthesis
- What is being tested?
- Bolus ingestion of protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2021to 15 Jun 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
- BMI between 18 and 30
- Resistance trained
Who cannot join
- Any metabolic impairment
- Smoking
- Use of over the counter pharmaceuticals (excluding oral contraceptives and contraceptive devices).
- A personal family history of epilepsy, seizures or schizophrenia.
- Allergic to Quorn/mycoprotein/edible fungi/environmental mould products.
- Any motor disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Postprandial Muscle Protein Synthesis Rates Following the Consumption of Mycoprotein, Pea Protein and a Mycoprotein/Pea Protein Blend in Resistance Trained Individuals
Dietary protein is vital for the preservation of health and optimal adaptation to training. Plant proteins are considered inferior to animal proteins with respect to their ability to stimulate an acute muscle building response and therefore support long-term muscle reconditioning. Pea protein is a highly commercially available plant proteins source (available as supplements, food ingredients etc.), yet there is no research investigating its ability to stimulate a muscle building response. The investigators aim to assess the effect of consuming pea protein on muscle protein synthesis rates and compare these results to mycoprotein, a source known to elicit a robust anabolic response.
Pea protein is lower in some of the essential amino acids, namely methionine, which could mean it is less effective compared with mycoprotein which has a more complete amino acid profile. So in addition to comparing pea with mycoprotein, the investigators also want to compare to a blend of pea and mycoprotein to see if replenishing the amino acid content in pea 'rescues' the anabolic response.
- Conditions
- Muscle Protein Synthesis
- Being tested
- Bolus ingestion of protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bolus ingestion of proteinDietary supplement
Also called Protein ingestion
Ingestion of 25g of protein
| Study group | Role | What they receive |
|---|---|---|
| Mycoprotein | Experimental | Bolus ingestion of mycoprotein providing 25g of protein. Receives: Dietary Supplement: Bolus ingestion of protein |
| Pea protein | Experimental | Bolus ingestion of pea protein providing 25g of protein. Receives: Dietary Supplement: Bolus ingestion of protein |
| Mycoprotein/pea protein dry blend | Experimental | Bolus ingestion of mycoprotein/pea protein dry blend providing 25g of protein. Receives: Dietary Supplement: Bolus ingestion of protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein synthesis
The rate of synthesis of new muscle protein (Fractional synthetic rate %/h)
Measured: 8.5 hours
Secondary outcomes (4)
Plasma amino acid kinetics
The appearance of amino acids from the protein drink in the circulation.
Measured: 8.5 hours
Serum insulin concentrations
Basal and postprandial concentrations of serum insulin
Measured: 8.5 hours
Translocation of mTOR via immunohistochemistry
Locality of mTOR within the muscle cell
Measured: 8.5 hours
mTOR phosphorylation via ATP kinase assay
The amount of mTOR that has been activated in the muscle cell
Measured: 8.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start1 May 2021
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Protein SynthesisStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- Quorn
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894747
- Sponsor's protocol ID
- 200325_B_04UOE
- Acronym
- BPM
- Status last verified
- Mar 2023
- First submitted
- 5 May 2021
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- 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 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Postprandial Muscle Protein Synthesis Rates Following the Consumption of Mycoprotein, Pea Protein and a Mycoprotein/Pea Protein Blend in Resistance Trained Individuals
- ClinicalTrials.gov ID
- NCT04894747
- Acronym / sponsor ID
- BPM / 200325_B_04UOE
- Conditions
- Muscle Protein Synthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- Quorn
- Study start
- 1 May 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 20 May 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.
Dietary protein is vital for the preservation of health and optimal adaptation to training. Plant proteins are considered inferior to animal proteins with respect to their ability to stimulate an acute muscle building response and therefore support long-term muscle reconditioning. Pea protein is a highly commercially available plant proteins source (available as supplements, food ingredients etc.), yet there is no research investigating its ability to stimulate a muscle building response. The investigators aim to assess the effect of consuming pea protein on muscle protein synthesis rates and compare these results to mycoprotein, a source known to elicit a robust anabolic response.
Pea protein is lower in some of the essential amino acids, namely methionine, which could mean it is less effective compared with mycoprotein which has a more complete amino acid profile. So in addition to comparing pea with mycoprotein, the investigators also want to compare to a blend of pea and mycoprotein to see if replenishing the amino acid content in pea 'rescues' the anabolic response.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mycoprotein | Experimental | Dietary Supplement: Bolus ingestion of proteinBolus ingestion of mycoprotein providing 25g of protein. |
| Pea protein | Experimental | Dietary Supplement: Bolus ingestion of proteinBolus ingestion of pea protein providing 25g of protein. |
| Mycoprotein/pea protein dry blend | Experimental | Dietary Supplement: Bolus ingestion of proteinBolus ingestion of mycoprotein/pea protein dry blend providing 25g of protein. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI between 18 and 30
- Resistance trained
Key exclusion criteria (6 listed)
- Any metabolic impairment
- Smoking
- Use of over the counter pharmaceuticals (excluding oral contraceptives and contraceptive devices).
- A personal family history of epilepsy, seizures or schizophrenia.
- Allergic to Quorn/mycoprotein/edible fungi/environmental mould products.
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 |
|---|---|---|
| Bolus ingestion of proteinAlso: Protein ingestionIngestion of 25g of protein | Dietary supplement | Mycoprotein, Mycoprotein/pea protein dry blend, Pea protein |
Primary outcome
Muscle protein synthesis
Time frame: 8.5 hours
The rate of synthesis of new muscle protein (Fractional synthetic rate %/h)
4 secondary outcomes
Plasma amino acid kinetics
Time frame: 8.5 hours
Serum insulin concentrations
Time frame: 8.5 hours
Translocation of mTOR via immunohistochemistry
Time frame: 8.5 hours
mTOR phosphorylation via ATP kinase assay
Time frame: 8.5 hours
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 22 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 Bolus ingestion of protein in people with Muscle Protein Synthesis, 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 6 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 22 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. 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 synthesis (time frame: 8.5 hours). 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 22 Mar 2023.