NCT05584358

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

February 2, 2022

Completed
9 months until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

January 11, 2024

Status Verified

January 1, 2024

Enrollment Period

1.6 years

First QC Date

January 24, 2022

Last Update Submit

January 10, 2024

Conditions

Postprandial Plasma Amino Acid Availability

Outcome Measures

Primary Outcomes (1)

  • Plasma amino acid concentrations

    The rate of appearance of amino acids ingested in the drink

    5 hours

Secondary Outcomes (3)

  • Blood glucose

    5 hours

  • Serum insulin

    5 hours

  • Resting metabolic rate

    5 hours

Study Arms (2)

Dry Blend

EXPERIMENTAL

A dry blend of mycoprotein and pea protein.

Dietary Supplement: Dry protein blend ingestion

Extrudate

EXPERIMENTAL

An extruded blend of mycoprotein and pea protein

Dietary Supplement: Extruded protein blend ingestion

Interventions

Dry protein blend ingestionDIETARY_SUPPLEMENT

Ingestion of protein blend powders mixed in water

Dry Blend
Extruded protein blend ingestionDIETARY_SUPPLEMENT

Ingestion of protein blend powders mixed in water

Extrudate

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 18 and 30.
  • Metabolically healthy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sport & Health Sciences University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

Location

University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

Location

Related Publications (1)

  • West S, Monteyne AJ, Whelehan G, Abdelrahman DR, Murton AJ, Finnigan TJ, Mandalari G, Booth C, Wilde PJ, Stephens FB, Wall BT. High-Moisture Extrusion of a Dietary Protein Blend Impairs In Vitro Digestion and Delays In Vivo Postprandial Plasma Amino Acid Availability in Humans. J Nutr. 2024 Jul;154(7):2053-2064. doi: 10.1016/j.tjnut.2024.05.018. Epub 2024 May 24.

    PMID: 38797481DERIVED

Study Officials

  • Benjamin Wall

    Professor of Nutritional Physiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2022

First Posted

October 18, 2022

Study Start

February 2, 2022

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

January 11, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)