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

Sponsor

University of Limerick (Other)

Overall Status

Completed

CT.gov ID

NCT05020808

Collaborator

Marigot Ltd. (Industry), Enterprise Ireland (Other)

Enrollment

Location

Arms

9.2

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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 kilogram of body mass.

Condition or Disease	Intervention/Treatment	Phase
Metabolism Exercise Dietary Supplements	Dietary Supplement: NEAA Dietary Supplement: PPI	N/A

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

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Block randomized control trial, parallel group designBlock randomized control trial, parallel group design

Masking:

Single (Participant)

Masking Description:

Single blind (participant)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Sep 14, 2021

Actual Primary Completion Date :

Jun 20, 2022

Actual Study Completion Date :

Jun 20, 2022

Arms and Interventions

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	Dietary Supplement: NEAA 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	Dietary Supplement: PPI Food grade plant (legume - Fava) protein isolate to be dissolved in water. Supplied by Marigot Ltd, Cork, Ireland Other Names: Plant Protein Isolate

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

Dietary Supplement: NEAA

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

Dietary Supplement: PPI

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

Other Names:

Plant Protein Isolate

Outcome Measures

Primary Outcome Measures

Myofibrillar fractional synthetic rate change [4 hours]
The fractional rate of myofibrillar protein synthesis measured by deuterium incorporation into skeletal muscle sampled by microbiopsy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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