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

Intervention / Treatment

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).
Other: Animal protein based diet
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).
Other: Low-nucleotide mycoprotein based diet
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.
Other: High-nucleotide mycoprotein based diet

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

University of Exeter

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.

General Publications

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.

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