NCT04084639

Brief Summary

Previous research has demonstrated that the food found in Quorn 'Mycoprotein' can lower the blood glucose response to a meal, which may be an important finding for the management of type 2 diabetes. However, it has never been investigated how this lower response occurs, and whether there is dose-dependent response with mycoprotein. The present study will include 12 healthy young adults, who will visit the laboratory for 3 test days, with each day lasting 9 hours. On each visit, separated by a washout period of at least 2 weeks, participants will ingest either a control drink with no mycoprotein, a drink containing 20g mycoprotein or a drink containing 40g mycoprotein. By intravenously infusing labelled glucose during each visit in combination with repeated blood sampling, investigators will determine if the lower blood glucose after mycoprotein ingestion is due to reduced glucose absorption from the gut or increased uptake into body tissues.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable healthy

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

August 28, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2019

Completed
Last Updated

November 8, 2019

Status Verified

November 1, 2019

Enrollment Period

2 months

First QC Date

September 6, 2019

Last Update Submit

November 6, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Glucose absorption

    How glucose is absorbed following the ingestion of a mycoprotein drink compared to a placebo control measured using the infusion of stable isotopes

    6 hours following ingestion of drink

Secondary Outcomes (4)

  • Incretin Hormones

    6 hours following ingestion of drink

  • Insulinaemic Response

    6 hours following ingestion of drink

  • Production of Short-Chain Fatty Acids

    6 hours following ingestion of drink

  • Glucose Kinetics

    6 hours following ingestion of drink

Study Arms (3)

Ingestion of 20g Mycoprotein Drink

EXPERIMENTAL

Milkshake containing 20g of mycoprotein, 250ml full-fat milk, 50g glucose and 11g lactose is given to participants in one dose

Dietary Supplement: Mycoprotein Ingestion

Ingestion of 40g Mycoprotein Drink

EXPERIMENTAL

Milkshake containing 40g of mycoprotein, 250ml full-fat milk, 50g glucose and 11g lactose is given to participants in one dose

Dietary Supplement: Mycoprotein Ingestion

Ingestion of Isocaloric Control Drink

PLACEBO COMPARATOR

Milkshake containing 250ml full-fat milk, 50g glucose, 19g dried skim milk and 9g full-fat dried milk

Dietary Supplement: Mycoprotein Ingestion

Interventions

Mycoprotein IngestionDIETARY_SUPPLEMENT

Ingestion of various doses of mycoprotein compared to placebo control

Ingestion of 20g Mycoprotein DrinkIngestion of 40g Mycoprotein DrinkIngestion of Isocaloric Control Drink

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female
  • years of age
  • Consumption of sufficient amounts of carbohydrate in the diet
  • Body mass index between 18.5 and 30

You may not qualify if:

  • Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes), or other form of abnormal glucose metabolism (as this will affect outcome of the study).
  • Any diagnosed cardiovascular disease
  • Insufficient consumption of carbohydrate in the diet
  • A personal or family history of epilepsy, seizures or schizophrenia
  • Known pre-existing liver disease/condition
  • Allergy or intolerance to milk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Exeter

Exeter, United Kingdom

Location

Related Publications (1)

  • Whelehan G, West S, Abdelrahman DR, Murton AJ, Finnigan TJA, Wall BT, Stephens FB. The addition of mycoprotein to a mixed-meal impacts postprandial glucose kinetics without altering blood glucose concentrations: a randomised controlled trial. Eur J Clin Nutr. 2024 Sep;78(9):757-764. doi: 10.1038/s41430-024-01470-4. Epub 2024 Jul 13.

    PMID: 39003347DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blind crossover design
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2019

First Posted

September 10, 2019

Study Start

August 28, 2019

Primary Completion

October 16, 2019

Study Completion

October 16, 2019

Last Updated

November 8, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)