Chronic Mycoprotein Consumption and Nucleotide Content in Metabolic Health (MYTH)
June 13, 2018 updated by: University of Exeter
Effect of Chronic Mycoprotein Consumption, and of Its Nucleotide Content, in Uric Acid Concentrations and Other Markers of Metabolic Health in Adults
Compare chronic (one week) of a 'normal' meat diet with one week of mycoprotein consumption, with or without a reduced nucleotide content, on markers of metabolic health, such as uric acid concentrations, blood glucose control and blood lipid profiles.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
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 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI between 18 and 30
Exclusion Criteria:
- On medication (except contraception)
- Smokers
- Diagnosed with any metabolic or cardiovascular conditions
- BMI < 18 or > 30
- Dietary restrictions (vegetarians/vegans, etc.)
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: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Animal protein based diet
Seven day fully controlled normocaloric diet (1.2 g/ kg body weight of protein per day), with the main protein source at the two main meals (lunch and dinner) being provided by animal products (meat and fish).
|
|
|
Active Comparator: Low-nucleotide mycoprotein based diet
Seven day fully controlled normocaloric diet (1.2 g/ kg body weight of protein per day), with the main protein source at the two main meals (lunch and dinner) being provided by nucleotide-depleted mycoprotein products (commercial Quorn products).
|
|
|
Active Comparator: High-nucleotide mycoprotein based diet
Seven day fully controlled normocaloric diet (1.2 g/ kg body weight of protein per day), with the main protein source at the two main meals (lunch and dinner) being provided by nucleotide-rich mycoprotein products.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Serum uric acid concentrations
Time Frame: Measured at baseline; days 2, 4 and 6 of the intervention; and after the 1 week intervention (day 8)
|
Measured at baseline; days 2, 4 and 6 of the intervention; and after the 1 week intervention (day 8)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Glycaemia and serum insulin - insulin sensitivity (oral glucose tolerance test)
Time Frame: Measured at baseline and after 1 week intervention (day 8)
|
Measured at baseline and after 1 week intervention (day 8)
|
|
IL-6
Time Frame: Measured at baseline and after 1 week intervention (day 8)
|
Measured at baseline and after 1 week intervention (day 8)
|
|
24 h blood glucose homeostasis - measured using a Dexcom CGMS
Time Frame: Measured 5 days at baseline (habitual data) and 5 days during the intervention (days 3 - 7)
|
Measured 5 days at baseline (habitual data) and 5 days during the intervention (days 3 - 7)
|
|
Metabolomics (using Nuclear Magnetic Resonance - NMR)
Time Frame: Measured at baseline; days 2, 4 and 6 of the intervention; and after the 1 week intervention (day 8)
|
Measured at baseline; days 2, 4 and 6 of the intervention; and after the 1 week intervention (day 8)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
January 1, 2017
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
December 2, 2016
First Submitted That Met QC Criteria
December 2, 2016
First Posted (Estimate)
December 6, 2016
Study Record Updates
Last Update Posted (Actual)
June 15, 2018
Last Update Submitted That Met QC Criteria
June 13, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 660065613
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
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.