- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04872530
Bioavailability of Plant Protein Amino Acids
November 29, 2023 updated by: University of Limerick
Bioavailability of Amino Acids and Metabolic Products Following Oral Ingestion of Plant-Based Proteins in Young, Healthy Men and Women Aged 18-35y
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rob Davies, PhD
- Phone Number: +353-(0)61-202700
- Email: robert.davies@ul.ie
Study Contact Backup
- Name: Phil Jakeman, PhD
- Email: phil.jakeman@ul.ie
Study Locations
-
-
-
Limerick, Ireland, V94 T9PX
- Education and Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pea-protein concentrate
Pea-protein concentrate dosed at 0.33 g/kg body mass in 500 ml of water.
|
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.
|
Fava-bean protein concentrate
|
Experimental: Chickpea protein concentrate
Chickpea protein concentrate dosed at 0.33 g/kg body mass in 500 ml of water.
|
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.
|
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.
|
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.
|
Whey protein concentrate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma amino acids
Time Frame: 3 hours
|
Plasma amino acids measured by HPLC
|
3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Phil Jakeman, PhD, University of Limerick
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 8, 2020
Primary Completion (Actual)
May 31, 2021
Study Completion (Actual)
September 29, 2023
Study Registration Dates
First Submitted
April 29, 2021
First Submitted That Met QC Criteria
April 29, 2021
First Posted (Actual)
May 4, 2021
Study Record Updates
Last Update Posted (Actual)
November 30, 2023
Last Update Submitted That Met QC Criteria
November 29, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2019_12_02_EHS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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