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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Low nucleotide meal; Other: High nucleotide meal

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Devon
    • Exeter, Devon, United Kingdom, EX1 2LU
      • St Luke's Campus - University of Exeter

Participation Criteria

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Low nucleotide meal; Mixed meal containing mycoprotein with a reduced nucleotide content (~ 2% nucleotides)	Other: Low nucleotide meal; The participants will consume a mixed meal (sandwich) containing a nucleotide depleted mycoprotein product (low in nucleotides)
Experimental: High nucleotide meal; Mixed meal containing mycoprotein with a high nucleotide content (~ 10% nucleotides)	Other: High nucleotide meal; The participants will consume a mixed meal (sandwich) containing a non nucleotide depleted mycoprotein product (high in nucleotides)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Exeter

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2017
• Primary Completion (Actual): March 14, 2018
• Study Completion (Actual): March 14, 2018

Study Registration Dates

• First Submitted: May 31, 2018
• First Submitted That Met QC Criteria: June 13, 2018
• First Posted (Actual): June 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 26, 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: 170712/A/01

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