The Effect of a Plant Protein Isolate on Muscle Protein Synthesis in Humans at Rest and After Resistance Exercise

NCT ID: NCT05020808

Last Updated: 2022-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-14

Study Completion Date

2022-06-20

Brief Summary

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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

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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

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Metabolism Exercise Dietary Supplements

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Block randomized control trial, parallel group design
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Single blind (participant)

Study Groups

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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

Group Type SHAM_COMPARATOR

NEAA

Intervention Type DIETARY_SUPPLEMENT

Food grade mixture of non-essential amino acids in powdered form to be dissolved in water. Supplied by Marigot Ltd, Cork, Ireland

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

Group Type ACTIVE_COMPARATOR

PPI

Intervention Type DIETARY_SUPPLEMENT

Food grade plant (legume - Fava) protein isolate to be dissolved in water. Supplied by Marigot Ltd, Cork, Ireland

Interventions

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NEAA

Food grade mixture of non-essential amino acids in powdered form to be dissolved in water. Supplied by Marigot Ltd, Cork, Ireland

Intervention Type DIETARY_SUPPLEMENT

PPI

Food grade plant (legume - Fava) protein isolate to be dissolved in water. Supplied by Marigot Ltd, Cork, Ireland

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Plant Protein Isolate

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marigot Ltd.

INDUSTRY

Sponsor Role collaborator

Enterprise Ireland

OTHER_GOV

Sponsor Role collaborator

University of Limerick

OTHER

Sponsor Role lead

Responsible Party

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Robert Davies

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philip M Jakeman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Limerick

Robert W Davies, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Limerick

Locations

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University of Limerick

Limerick, Munster, Ireland

Site Status

Countries

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Ireland

Other Identifiers

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2020_04_07_EHS

Identifier Type: -

Identifier Source: org_study_id

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