High Nucleotide Meal Consumption in Uric Acid and Metabolic Health
TIDE
The Acute Effect of a High Nucleotide Mycoprotein Meal in Uric Acid Concentrations and Other Markers of Health
1 other identifier
interventional
10
1 country
1
Brief Summary
The production of protein rich animal products is associated with a large environmental burden, and with ethical considerations. Additionally, the over-consumption of meat might be associated with detrimental effects to health. Using mycoprotein, a food ingredient derived from the fermentation of a fungus, as a meat substitute could result in environmental benefits, and could have a role in managing obesity, diabetes and improving metabolic health. However, naturally produced mycoprotein has a high nucleotide content and little is known about the impact of nucleotides in uric acid levels and other health markers. The aim of this study is to investigate the effect of a meal based on nucleotide rich mycoprotein on uric acid concentrations and other markers of health.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Jul 2017
1 active site
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
Study Start
First participant enrolled
July 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 14, 2018
CompletedFirst Submitted
Initial submission to the registry
May 31, 2018
CompletedFirst Posted
Study publicly available on registry
June 26, 2018
CompletedJune 26, 2018
June 1, 2018
8 months
May 31, 2018
June 13, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in serum uric acid concentrations over a 24 h period
Baseline; 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes after meal; 8, 12 and 24 hours after meal
Secondary Outcomes (3)
Blood glucose
Baseline; 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes after meal; 24 hours after meal
Serum insulin
Baseline; 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes after meal
Branched chained amino-acids
Baseline; 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes after meal
Study Arms (2)
Low nucleotide meal
PLACEBO COMPARATORMixed meal containing mycoprotein with a reduced nucleotide content (\~ 2% nucleotides)
High nucleotide meal
EXPERIMENTALMixed meal containing mycoprotein with a high nucleotide content (\~ 10% nucleotides)
Interventions
The participants will consume a mixed meal (sandwich) containing a nucleotide depleted mycoprotein product (low in nucleotides)
The participants will consume a mixed meal (sandwich) containing a non nucleotide depleted mycoprotein product (high in nucleotides)
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St Luke's Campus - University of Exeter
Exeter, Devon, EX1 2LU, United Kingdom
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2018
First Posted
June 26, 2018
Study Start
July 31, 2017
Primary Completion
March 14, 2018
Study Completion
March 14, 2018
Last Updated
June 26, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share