Chronic Mycoprotein Consumption and Nucleotide Content in Metabolic Health
MYTH
Effect of Chronic Mycoprotein Consumption, and of Its Nucleotide Content, in Uric Acid Concentrations and Other Markers of Metabolic Health in Adults
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Jan 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2016
CompletedFirst Posted
Study publicly available on registry
December 6, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJune 15, 2018
June 1, 2018
11 months
December 2, 2016
June 13, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Serum uric acid concentrations
Measured at baseline; days 2, 4 and 6 of the intervention; and after the 1 week intervention (day 8)
Secondary Outcomes (4)
Glycaemia and serum insulin - insulin sensitivity (oral glucose tolerance test)
Measured at baseline and after 1 week intervention (day 8)
IL-6
Measured at baseline and after 1 week intervention (day 8)
24 h blood glucose homeostasis - measured using a Dexcom CGMS
Measured 5 days at baseline (habitual data) and 5 days during the intervention (days 3 - 7)
Metabolomics (using Nuclear Magnetic Resonance - NMR)
Measured at baseline; days 2, 4 and 6 of the intervention; and after the 1 week intervention (day 8)
Study Arms (3)
Animal protein based diet
PLACEBO COMPARATORSeven 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).
Low-nucleotide mycoprotein based diet
ACTIVE COMPARATORSeven 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).
High-nucleotide mycoprotein based diet
ACTIVE COMPARATORSeven 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.
Interventions
Eligibility Criteria
You may qualify if:
- BMI between 18 and 30
You may not qualify if:
- On medication (except contraception)
- Smokers
- Diagnosed with any metabolic or cardiovascular conditions
- BMI \< 18 or \> 30
- Dietary restrictions (vegetarians/vegans, etc.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Coelho MOC, Monteyne AJ, Kamalanathan ID, Najdanovic-Visak V, Finnigan TJA, Stephens FB, Wall BT. High dietary nucleotide consumption for one week increases circulating uric acid concentrations but does not compromise metabolic health: A randomised controlled trial. Clin Nutr ESPEN. 2022 Jun;49:40-52. doi: 10.1016/j.clnesp.2022.04.022. Epub 2022 Apr 25.
PMID: 35623844DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2016
First Posted
December 6, 2016
Study Start
January 1, 2017
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
June 15, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share