NCT02984358

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2017

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
26 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 15, 2018

Status Verified

June 1, 2018

Enrollment Period

11 months

First QC Date

December 2, 2016

Last Update Submit

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 COMPARATOR

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

Low-nucleotide mycoprotein based diet

ACTIVE COMPARATOR

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

High-nucleotide mycoprotein based diet

ACTIVE COMPARATOR

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

Interventions

Animal protein based diet
Low-nucleotide mycoprotein based diet
High-nucleotide mycoprotein based diet

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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.

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