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

Exercise Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05020808
• Other study ID #: 2020_04_07_EHS
• Status: Completed
• Phase: N/A
• Start date: September 14, 2021
• Est. completion date: June 20, 2022

Study information

• Verified date: June 2022
• Source: University of Limerick
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 kilogram of body mass.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 20, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Dietary Supplements
• Exercise
• Metabolism

Intervention

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

Locations

Country	Name	City	State
Ireland	University of Limerick	Limerick	Munster

Sponsors (3)

Lead Sponsor	Collaborator
University of Limerick	Enterprise Ireland, Marigot Ltd.

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myofibrillar fractional synthetic rate change	The fractional rate of myofibrillar protein synthesis measured by deuterium incorporation into skeletal muscle sampled by microbiopsy	4 hours