MetabolismNCT05020808
The Effect of a Plant Protein Isolate on Muscle Protein Synthesis in Humans at Rest and After Resistance Exercise
A study testing NEAA and PPI in people with Metabolism and Exercise, run by University of Limerick at 1 site in Ireland.
Trial summary
Plant-based proteins contain several amino acids that are essential to signal growth, reconditioning, maintenance and preservation of skeletal muscle mass. This study aims to inform on the nutrient activation of muscle protein synthesis (MPS) by feeding a plant protein isolate equivalent to 0.33 g of protein per… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolism, Exercise, Dietary Supplements
- What is being tested?
- NEAA and PPI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteIreland
- Study dates
- 14 Sep 2021to 20 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged 18 to 35 years
Who cannot join
- Known intolerance to any item contained in the protein products.
- Blood borne disease risk, current illness or medication that would adversely affect participation
- Known adverse reaction to venepuncture and/or biopsy
- Inability to undertake resistance exercise
- Inability to adhere to protocol guidelines
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Plant Protein Isolate on Muscle Protein Synthesis in Humans at Rest, and After Resistance Exercise: A Randomized Controlled Trial
Plant-based proteins contain several amino acids that are essential to signal growth, reconditioning, maintenance and preservation of skeletal muscle mass. This study aims to inform on the nutrient activation of muscle protein synthesis (MPS) by feeding a plant protein isolate equivalent to 0.33 g of protein per kilogram of body mass.
Read the detailed description
Participants: 32 young, healthy men and women aged 18 - 35 years. Intervention: Plant protein isolate (PPI) and nonessential amino acid control (NEAA) Study Design: Block randomised control trial. Two group parallel design. Primary outcome: Myofibrillar fractional synthetic rate (myoFSR).
Preliminary screening/familiarization consists of: medical history, dietary assessment and examination by a medical doctor and a qualified dietician, blood sample to be evaluated for health-related contraindications, body composition measurement by dual energy x-ray absorptiometry (DXA), isokinetic knee extensor strength tests.
Pre-trial: A metered dose of deuterium oxide (5ml/kg) will be ingested and blood and/or saliva (~5ml) samples will be collected pre/post ingestion.
Experimental trial: Blood, saliva and bilateral m.vastus lateralis microbiopsies (~100 mg) collected. A unilateral resistance-training session consisting of knee extensor contractions will be completed. Following exercise cessation participants will ingest 0.33 g/kg body mass of either: a nonessential amino acid formulation or a plant-protein isolate. A saliva sample and a 2nd set of bilateral m.vastus lateralis microbiopsies are collected 3 h postingestion.
- Conditions
- Metabolism, Exercise, Dietary Supplements
- Being tested
- NEAA, PPI
- Keywords
- amino acids, deuterium oxide, humans, protein synthesis, plant proteins, resistance training, skeletal muscle
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEAADietary supplement
Food grade mixture of non-essential amino acids in powdered form to be dissolved in water. Supplied by Marigot Ltd, Cork, Ireland
PPIDietary supplement
Also called Plant Protein Isolate
Food grade plant (legume - Fava) protein isolate to be dissolved in water. Supplied by Marigot Ltd, Cork, Ireland
| Study group | Role | What they receive |
|---|---|---|
| Nonessential amino acid formulation (NEAA) | Sham comparator | Novel non-essential amino acid blend dosed at 0.33 g/kg body mass in 400 ml of water. Postprandial muscle protein synthesis at rest, and after resistance exercise to be measured by deuterium incorporation in to skeletal muscle sampled by bilateral microbiopsies.
Product Number: NEAA56812 Receives: Dietary Supplement: NEAA |
| Plant Protein Isolate (PPI) | Active comparator | Plant protein isolate (Fava bean) dosed at 0.33 g/kg body mass in 400 ml of water. Postprandial muscle protein synthesis at rest, and after resistance exercise to be measured by deuterium incorporation in to skeletal muscle sampled by bilateral microbiopsies.
Product Number: FP2011273 Receives: Dietary Supplement: PPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myofibrillar fractional synthetic rate change
The fractional rate of myofibrillar protein synthesis measured by deuterium incorporation into skeletal muscle sampled by microbiopsy
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start14 Sep 2021
- Primary completion20 Jun 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetabolismStudies 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
- Model description
- Block randomized control trial, parallel group design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Collaborators
- Marigot Ltd., Enterprise Ireland
- Responsible party
- Principal investigator, Robert Davies, University of Limerick
- Investigators
- Philip M Jakeman, PhD, Principal investigator, University of LimerickRobert W Davies, PhD, Principal investigator, University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020808
- Sponsor's protocol ID
- 2020_04_07_EHS
- Status last verified
- Jun 2022
- First submitted
- 17 Aug 2021
- Last updated
- 22 Jun 2022
- 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 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Plant Protein Isolate on Muscle Protein Synthesis in Humans at Rest, and After Resistance Exercise: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05020808
- Acronym / sponsor ID
- 2020_04_07_EHS
- Conditions
- Metabolism, Exercise, Dietary Supplements
- Keywords
- amino acids, deuterium oxide, humans, protein synthesis, plant proteins, resistance training, skeletal muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Collaborators
- Marigot Ltd., Enterprise Ireland
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 25 Aug 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.
Plant-based proteins contain several amino acids that are essential to signal growth, reconditioning, maintenance and preservation of skeletal muscle mass. This study aims to inform on the nutrient activation of muscle protein synthesis (MPS) by feeding a plant protein isolate equivalent to 0.33 g of protein per kilogram of body mass.
Detailed description
Participants: 32 young, healthy men and women aged 18 - 35 years. Intervention: Plant protein isolate (PPI) and nonessential amino acid control (NEAA) Study Design: Block randomised control trial. Two group parallel design. Primary outcome: Myofibrillar fractional synthetic rate (myoFSR).
Preliminary screening/familiarization consists of: medical history, dietary assessment and examination by a medical doctor and a qualified dietician, blood sample to be evaluated for health-related contraindications, body composition measurement by dual energy x-ray absorptiometry (DXA), isokinetic knee extensor strength tests.
Pre-trial: A metered dose of deuterium oxide (5ml/kg) will be ingested and blood and/or saliva (~5ml) samples will be collected pre/post ingestion.
Experimental trial: Blood, saliva and bilateral m.vastus lateralis microbiopsies (~100 mg) collected. A unilateral resistance-training session consisting of knee extensor contractions will be completed. Following exercise cessation participants will ingest 0.33 g/kg body mass of either: a nonessential amino acid formulation or a plant-protein isolate. A saliva sample and a 2nd set of bilateral m.vastus lateralis microbiopsies are collected 3 h postingestion.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Block randomized control trial, parallel group design
| Arm | Type | Receives |
|---|---|---|
| Nonessential amino acid formulation (NEAA) | Sham comparator | Dietary Supplement: NEAANovel non-essential amino acid blend dosed at 0.33 g/kg body mass in 400 ml of water. Postprandial muscle protein synthesis at rest, and after resistance exercise to be measured by deuterium incorporation in to skeletal muscle sampled by bilateral microbiopsies. Product Number: NEAA56812 |
| Plant Protein Isolate (PPI) | Active comparator | Dietary Supplement: PPIPlant protein isolate (Fava bean) dosed at 0.33 g/kg body mass in 400 ml of water. Postprandial muscle protein synthesis at rest, and after resistance exercise to be measured by deuterium incorporation in to skeletal muscle sampled by bilateral microbiopsies. Product Number: FP2011273 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Men and women aged 18 to 35 years
Key exclusion criteria (5 listed)
- Known intolerance to any item contained in the protein products.
- Blood borne disease risk, current illness or medication that would adversely affect participation
- Known adverse reaction to venepuncture and/or biopsy
- Inability to undertake resistance exercise
- Inability to adhere to protocol guidelines
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 |
|---|---|---|
| NEAAFood grade mixture of non-essential amino acids in powdered form to be dissolved in water. Supplied by Marigot Ltd, Cork, Ireland | Dietary supplement | Nonessential amino acid formulation (NEAA) |
| PPIAlso: Plant Protein IsolateFood grade plant (legume - Fava) protein isolate to be dissolved in water. Supplied by Marigot Ltd, Cork, Ireland | Dietary supplement | Plant Protein Isolate (PPI) |
Primary outcome
Myofibrillar fractional synthetic rate change
Time frame: 4 hours
The fractional rate of myofibrillar protein synthesis measured by deuterium incorporation into skeletal muscle sampled by microbiopsy
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 Jun 2022.
- 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.
Philip M Jakeman, PhD principal investigator
University of Limerick
Robert W Davies, PhD principal investigator
University of Limerick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEAA and PPI in people with Metabolism and Exercise, run by University of Limerick at 1 site in Ireland.
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 5 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 Jun 2022. 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 Ireland. 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?
Myofibrillar fractional synthetic rate change (time frame: 4 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 Jun 2022.