Protein Extrusion and Postprandial Amino Acid Handling (BABE)

January 10, 2024 updated by: University of Exeter

The Impact of the Extrusion Process During Dietary Protein Production on in Vivo Postprandial Amino Acid Availability

The bulk of research that has investigated the effect of dietary protein on muscle tissue in humans has used isolated, minimally processed protein powders. However, the protein that we consume on a daily basis has typically undergone various processing methods, and evidence suggests these can change the way our bodies metabolise the protein. 'Extrusion' is a common processing method that uses high pressure to produce protein containing cereals and meat replacement foods. There is currently no research looking at how extrusion affects the way a protein source is digested and absorbed in humans. This study will compare the availability of ingested protein in the blood in the hours following consumption of an extruded versus a non-extruded source.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

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 Locations

  • United Kingdom
    • Devon
      • Exeter, Devon, United Kingdom, EX1 2LU
        • University of Exeter
      • Exeter, Devon, United Kingdom, EX1 2LU
        • Sport & Health Sciences University of Exeter

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 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • BMI between 18 and 30.
  • Metabolically healthy

Exclusion Criteria:

  • Any metabolic impairments
  • cardio/pulmonary diseases.
  • Chronic use of the over the counter medicine
  • A personal or family history of epilepsy, seizures or schizophrenia.
  • Allergic to mycoprotein/Quorn/edible fungi/environmental mould products.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dry Blend
A dry blend of mycoprotein and pea protein.
Dietary supplement: Dry protein blend ingestion
Ingestion of protein blend powders mixed in water
Experimental: Extrudate
An extruded blend of mycoprotein and pea protein
Dietary supplement: Extruded protein blend ingestion
Ingestion of protein blend powders mixed in water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma amino acid concentrations
Time Frame: 5 hours
The rate of appearance of amino acids ingested in the drink
5 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood glucose
Time Frame: 5 hours
The concentrations of glucose in the blood
5 hours
Serum insulin
Time Frame: 5 hours
The concentration of insulin in the blood
5 hours
Resting metabolic rate
Time Frame: 5 hours
The amount of energy used to digest the protein
5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Exeter

Collaborators

Quorn

Investigators

  • Principal Investigator: Benjamin Wall, Professor of Nutritional Physiology

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)

February 2, 2022

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

January 24, 2022

First Submitted That Met QC Criteria

October 17, 2022

First Posted (Actual)

October 18, 2022

Study Record Updates

Last Update Posted (Actual)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 21-10-20-A-06 v2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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