- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04084639
Mycoprotein Consumption and Glucose Absorption (MEGA)
November 6, 2019 updated by: University of Exeter
To Determine the Effects of Mycoprotein Consumption on Glucose Absorption in Healthy Participants
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
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
-
-
-
Exeter, United Kingdom
- 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 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female
- 18-35 years of age
- Consumption of sufficient amounts of carbohydrate in the diet
- Body mass index between 18.5 and 30
Exclusion Criteria:
- 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
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ingestion of 20g Mycoprotein Drink
Milkshake containing 20g of mycoprotein, 250ml full-fat milk, 50g glucose and 11g lactose is given to participants in one dose
|
Ingestion of various doses of mycoprotein compared to placebo control
|
Experimental: Ingestion of 40g Mycoprotein Drink
Milkshake containing 40g of mycoprotein, 250ml full-fat milk, 50g glucose and 11g lactose is given to participants in one dose
|
Ingestion of various doses of mycoprotein compared to placebo control
|
Placebo Comparator: Ingestion of Isocaloric Control Drink
Milkshake containing 250ml full-fat milk, 50g glucose, 19g dried skim milk and 9g full-fat dried milk
|
Ingestion of various doses of mycoprotein compared to placebo control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose absorption
Time Frame: 6 hours following ingestion of drink
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incretin Hormones
Time Frame: 6 hours following ingestion of drink
|
Measurement of glucagon-like peptide-1(GLP-1) and gastric inhibitory polypeptide (GIP) in response to mycoprotein ingestion compared to placebo control
|
6 hours following ingestion of drink
|
Insulinaemic Response
Time Frame: 6 hours following ingestion of drink
|
Measurement of insulin response following ingestion of drinks
|
6 hours following ingestion of drink
|
Production of Short-Chain Fatty Acids
Time Frame: 6 hours following ingestion of drink
|
Measurement of plasma acetate production in response to mycoprotein ingestion
|
6 hours following ingestion of drink
|
Glucose Kinetics
Time Frame: 6 hours following ingestion of drink
|
Calculations using plasma deuterated glucose enrichment to determine rate of appearance of endogenous glucose, rate of disappearance of glucose and rate of appearance of exogenous glucose
|
6 hours following ingestion of drink
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
August 28, 2019
Primary Completion (Actual)
October 16, 2019
Study Completion (Actual)
October 16, 2019
Study Registration Dates
First Submitted
September 6, 2019
First Submitted That Met QC Criteria
September 6, 2019
First Posted (Actual)
September 10, 2019
Study Record Updates
Last Update Posted (Actual)
November 8, 2019
Last Update Submitted That Met QC Criteria
November 6, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 190206/B/06
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
product manufactured in and exported from the U.S.
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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