Bioavailability of Plant Protein Amino Acids

• Sponsor: University of Limerick (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04872530
• Collaborator: Marigot Ltd. (Industry), Enterprise Ireland (Other)
• Enrollment: 10
• Location: 1
• Arms: 6
• Anticipated Duration (Months): 15.7
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

This study aims to inform of the mechanism of action of plant-based protein by measuring the bioavailability (i.e. rate of appearance and magnitude of concentration in the circulation following oral ingestion) of key amino acid and metabolic products that regulate skeletal muscle protein synthesis (MPS) in humans.

Condition or Disease	Intervention/Treatment	Phase
Bioavailability of Amino Acids Following Oral Ingestion of Plant-Based Proteins in Young, Healthy Men	Dietary Supplement: Pea-protein concentrate; Dietary Supplement: Fava-bean protein concentrate; Dietary Supplement: Chickpea protein concentrate; Dietary Supplement: Red lentil protein concentrate; Dietary Supplement: Non-essential amino acid blend; Dietary Supplement: Whey protein concentrate	N/A

Detailed Description

Plant-based proteins contain several amino acids that are essential to signal muscle growth/repair and act as a substrate during muscle protein synthesis. However, compared to animal protein or free-amino acids, the bioavailability of certain essential amino acids may be compromised. Following selective processing (e.g. removal of carbohydrate and/or other anti-nutritive factors) food grade plant-based protein concentrates possibly confer greater bioavailability and bioactivity in vivo. This project explores the bioavailability and bioactivity of selected plant-based protein concentrates following oral ingestion in young, healthy men and women.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Subjects who volunteer for this study will undertake SIX controlled feeding trials, each trial separated by 7 days.Subjects will be assigned to a randomised sequence of six protein isolates including: (1) pea-protein concentrate; (2) fava-bean protein concentrate; (3) chickpea protein concentrate; (4) red lentil protein concentrate; (5) non-essential amino acid blend (negative control);( 6) whey protein concentrate. Protein is dosed at 0.33 g/kg body mass in 500 ml of water.Subjects who volunteer for this study will undertake SIX controlled feeding trials, each trial separated by 7 days.Subjects will be assigned to a randomised sequence of six protein isolates including: (1) pea-protein concentrate; (2) fava-bean protein concentrate; (3) chickpea protein concentrate; (4) red lentil protein concentrate; (5) non-essential amino acid blend (negative control);( 6) whey protein concentrate. Protein is dosed at 0.33 g/kg body mass in 500 ml of water.
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Bioavailability of Amino Acids and Metabolic Products Following Oral Ingestion of Plant-Based Proteins in Young, Healthy Men and Women Aged 18-35y
• Actual Study Start Date: Jan 8, 2020
• Anticipated Primary Completion Date: May 1, 2021
• Anticipated Study Completion Date: May 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pea-protein concentrate Pea-protein concentrate dosed at 0.33 g/kg body mass in 500 ml of water.	Dietary Supplement: Pea-protein concentrate; Pea-protein concentrate
Experimental: Fava-bean protein concentrate Fava-bean protein concentrate dosed at 0.33 g/kg body mass in 500 ml of water.	Dietary Supplement: Fava-bean protein concentrate; Fava-bean protein concentrate
Experimental: Chickpea protein concentrate Chickpea protein concentrate dosed at 0.33 g/kg body mass in 500 ml of water.	Dietary Supplement: Chickpea protein concentrate; Chickpea protein concentrate
Experimental: Red lentil protein concentrate Red lentil protein concentrate dosed at 0.33 g/kg body mass in 500 ml of water.	Dietary Supplement: Red lentil protein concentrate; Red lentil protein concentrate
Experimental: Non-essential amino acid blend Non-essential amino acid blend dosed at 0.33 g/kg body mass in 500 ml of water.	Dietary Supplement: Non-essential amino acid blend; Non-essential amino acid blend
Experimental: Whey protein concentrate Whey protein concentrate dosed at 0.33 g/kg body mass in 500 ml of water.	Dietary Supplement: Whey protein concentrate; Whey protein concentrate

Outcome Measures

Primary Outcome Measures

1. Plasma amino acids [3 hours]

   Plasma amino acids measured by HPLC

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• No known intolerance to any item contained in the protein products.

• No blood borne disease risk, current illness or medication that would adversely affect participation

• No known adverse reaction to venepuncture

Exclusion Criteria:

• n/a

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Education and Health Sciences	Limerick		Ireland	V94 T9PX

Sponsors and Collaborators

• University of Limerick
• Marigot Ltd.
• Enterprise Ireland

Investigators

• Principal Investigator: Phil Jakeman, PhD, University of Limerick

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Limerick
• ClinicalTrials.gov Identifier: NCT04872530
• Other Study ID Numbers: 2019_12_02_EHS
• First Posted: May 4, 2021
• Last Update Posted: May 4, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Limerick: Bioavailability of Amino Acids Following Oral Ingestion of Plant-Based Proteins in Young, Healthy Men

Study Results

No Results Posted as of May 4, 2021