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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04084639
Other study ID # 190206/B/06
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 28, 2019
Est. completion date October 16, 2019

Study information

Verified date November 2019
Source University of Exeter
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date October 16, 2019
Est. primary completion date October 16, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Mycoprotein Ingestion
Ingestion of various doses of mycoprotein compared to placebo control

Locations

Country Name City State
United Kingdom University of Exeter Exeter

Sponsors (2)

Lead Sponsor Collaborator
University of Exeter Quorn Foods

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Incretin Hormones 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
Secondary Insulinaemic Response Measurement of insulin response following ingestion of drinks 6 hours following ingestion of drink
Secondary Production of Short-Chain Fatty Acids Measurement of plasma acetate production in response to mycoprotein ingestion 6 hours following ingestion of drink
Secondary Glucose Kinetics 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
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