NCT05020808

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

September 14, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2022

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

9 months

First QC Date

August 17, 2021

Last Update Submit

June 20, 2022

Conditions

Keywords

amino acidsdeuterium oxidehumansprotein synthesisplant proteinsresistance trainingskeletal muscle

Outcome Measures

Primary Outcomes (1)

  • Myofibrillar fractional synthetic rate change

    The fractional rate of myofibrillar protein synthesis measured by deuterium incorporation into skeletal muscle sampled by microbiopsy

    4 hours

Study Arms (2)

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

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

Dietary Supplement: PPI

Interventions

NEAADIETARY_SUPPLEMENT

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

Nonessential amino acid formulation (NEAA)
PPIDIETARY_SUPPLEMENT

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

Also known as: Plant Protein Isolate
Plant Protein Isolate (PPI)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Men and women aged 18 to 35 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Limerick

Limerick, Munster, V94 T9PX, Ireland

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Philip M Jakeman, PhD

    University of Limerick

    PRINCIPAL INVESTIGATOR
  • Robert W Davies, PhD

    University of Limerick

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single blind (participant)
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Block randomized control trial, parallel group design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 17, 2021

First Posted

August 25, 2021

Study Start

September 14, 2021

Primary Completion

June 20, 2022

Study Completion

June 20, 2022

Last Updated

June 22, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations