- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05020808
The Effect of a Plant Protein Isolate on Muscle Protein Synthesis in Humans at Rest and After Resistance Exercise
The Effect of a Plant Protein Isolate on Muscle Protein Synthesis in Humans at Rest, and After Resistance Exercise: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Munster
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Limerick, Munster, Ireland, V94 T9PX
- University of Limerick
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men and women aged 18 to 35 years
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Nonessential amino acid formulation (NEAA)
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 |
Food grade mixture of non-essential amino acids in powdered form to be dissolved in water.
Supplied by Marigot Ltd, Cork, Ireland
|
Active Comparator: Plant Protein Isolate (PPI)
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 |
Food grade plant (legume - Fava) protein isolate to be dissolved in water.
Supplied by Marigot Ltd, Cork, Ireland
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
4 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert W Davies, PhD, University of Limerick
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2020_04_07_EHS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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