Does the Ingestion of Mycoprotein Elicit an Optimal Anabo... | NCT02984345

Studies
Does the Ingestion of Mycoprotein Elicit an Optimal Anabolic Response in Resting and Exercised Skeletal Muscle?

NCT02984345

Sponsor

University of Exeter

Status

Completed

Last Update Posted

Apr 30, 2025Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Mycoprotein beverage
Milk protein beverage

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 26, 2017Actual

Primary Completion Date

May 1, 2018Actual

Completion Date

May 1, 2022Actual

First Submitted Date

Dec 2, 2016

First Submission Date that Met QC Criteria

Dec 2, 2016

First Posted Date

Dec 6, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2025

Last Update Posted Date

Apr 30, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The present study will seek to quantify the muscle protein synthetic response to mycoprotein feeding, comparing it to milk protein as a gold standard and heavily researched positive control

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mycoprotein beverage	Active Comparator		Other: Mycoprotein beverage
Milk protein beverage	Placebo Comparator		Other: Milk protein beverage

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mycoprotein beverage	Other	Mycoprotein protein beverage	Mycoprotein beverage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Muscle fractional synthetic rate (muscle protein synthesis)		7.5 hours

Secondary Outcomes

Measure	Description	Time Frame
Plasma amino acid concentration		7.5 hours
Serum insulin concentration		7.5 hours
Molecular markers of muscle anabolism

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• BMI between 18 and 30 -

Exclusion Criteria:

Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes)
Any diagnosed cardiovascular disease or hypertension.
Elevated blood pressure at the time of screening (e.g. blood pressure of ≥140/90mmHg).
Chronic use of any prescribed or over the counter pharmaceuticals.
A personal or family history of epilepsy, seizures or schizophrenia.
Anyone with previous motor disorders.
An allergy to mycoprotein / Quorn, penicillin, or milk.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Exeter, Sports & Health Sciences, College of Life & Environmental Sciences		Exeter	Devon	EX1 2LU	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided