NCT04233411

Brief Summary

To evaluate the bioavailability of mycoprotein, compared with a reference animal based protein, in a dose-response manner.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
2 years until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

1.6 years

First QC Date

November 30, 2016

Last Update Submit

January 15, 2020

Conditions

Availability of Mycoprotein

Outcome Measures

Primary Outcomes (1)

  • Plasma total amino acid concentrations

    4 hours

Study Arms (5)

Milk

ACTIVE COMPARATOR

Acute ingestion of 20 g milk protein

Other: Mycoprotein ingestion

20g

EXPERIMENTAL

Acute ingestion of 20 g mycoprotein

Other: Mycoprotein ingestion

40g

EXPERIMENTAL

Acute ingestion of 40 g mycoprotein

Other: Mycoprotein ingestion

60g

EXPERIMENTAL

Acute ingestion of 60 g mycoprotein

Other: Mycoprotein ingestion

80g

EXPERIMENTAL

Acute ingestion of 60 g mycoprotein

Other: Mycoprotein ingestion

Interventions

Mycoprotein ingestionOTHER
20g40g60g80gMilk

Eligibility Criteria

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

You may qualify if:

  • Healthy and aged 18-40 y
  • BMI between 18 and 30

You may not qualify if:

  • On medication
  • Family history of metabolic disease
  • Diagnosed with any metabolic or cardiovascular conditions
  • BMI \< 18 or \> 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sport & Health Sciences

Exeter, Devon, EX1 2LU, United Kingdom

Location

Study Officials

  • Benjamin T Wall, PhD

    University of Exeter, College of Life and Environmental Sciences

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 30, 2016

First Posted

January 18, 2020

Study Start

January 1, 2016

Primary Completion

August 1, 2017

Study Completion

January 1, 2018

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)