NCT04872530

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2023

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

1.4 years

First QC Date

April 29, 2021

Last Update Submit

November 29, 2023

Conditions

Bioavailability of Amino Acids Following Oral Ingestion of Plant-Based Proteins in Young, Healthy Men

Keywords

Bioavailability of Amino Acids Following Oral Ingestion of Plant-Based Proteins in Young, Healthy Men

Outcome Measures

Primary Outcomes (1)

  • Plasma amino acids

    Plasma amino acids measured by HPLC

    3 hours

Study Arms (6)

Pea-protein concentrate

EXPERIMENTAL

Pea-protein concentrate dosed at 0.33 g/kg body mass in 500 ml of water.

Dietary Supplement: Pea-protein concentrate

Fava-bean protein concentrate

EXPERIMENTAL

Fava-bean protein concentrate dosed at 0.33 g/kg body mass in 500 ml of water.

Dietary Supplement: Fava-bean protein concentrate

Chickpea protein concentrate

EXPERIMENTAL

Chickpea protein concentrate dosed at 0.33 g/kg body mass in 500 ml of water.

Dietary Supplement: Chickpea protein concentrate

Red lentil protein concentrate

EXPERIMENTAL

Red lentil protein concentrate dosed at 0.33 g/kg body mass in 500 ml of water.

Dietary Supplement: Red lentil protein concentrate

Non-essential amino acid blend

EXPERIMENTAL

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

Whey protein concentrate

EXPERIMENTAL

Whey protein concentrate dosed at 0.33 g/kg body mass in 500 ml of water.

Dietary Supplement: Whey protein concentrate

Interventions

Pea-protein concentrateDIETARY_SUPPLEMENT

Pea-protein concentrate

Pea-protein concentrate
Fava-bean protein concentrateDIETARY_SUPPLEMENT

Fava-bean protein concentrate

Fava-bean protein concentrate
Chickpea protein concentrateDIETARY_SUPPLEMENT

Chickpea protein concentrate

Chickpea protein concentrate
Red lentil protein concentrateDIETARY_SUPPLEMENT

Red lentil protein concentrate

Red lentil protein concentrate
Non-essential amino acid blendDIETARY_SUPPLEMENT

Non-essential amino acid blend

Non-essential amino acid blend
Whey protein concentrateDIETARY_SUPPLEMENT

Whey protein concentrate

Whey protein concentrate

Eligibility Criteria

Age18 Years - 35 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsHealthy young men
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • n/a

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Education and Health Sciences

Limerick, V94 T9PX, Ireland

Location

MeSH Terms

Interventions

Whey

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Phil Jakeman, PhD

    University of Limerick

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2021

First Posted

May 4, 2021

Study Start

January 8, 2020

Primary Completion

May 31, 2021

Study Completion

September 29, 2023

Last Updated

November 30, 2023

Record last verified: 2023-11

Locations

IE(1)