Quorn in Community Health Experiment (QUICHE)

March 21, 2023 updated by: University of Exeter
In overweight individuals (BMI > 27.5 kg/m2), does daily consumption of mycoprotein containing Quorn Food products lower blood cholesterol compared with daily meat/fish consumption?

Study Overview

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Devon
      • Exeter, Devon, United Kingdom, EX1 2LU
        • University of Exeter

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-70 years old
  • BMI >27.5 kg/m2
  • Non allergic to penicillin/mycoprotein
  • Moderate levels of physical activity or below (self-identified; NDNS servey)
  • Omnivores
  • Not currently using cholesterol lowering medication

Exclusion Criteria:

  • <18 or >70 years old
  • BMI <27.5 kg/m2
  • Allergies to penicillin/mycoprotein
  • Heavy exercisers (self idenfiied)
  • Vegetarian/vegans
  • Currently using cholesterol lowering medication

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Quorn Food products
180 g mycoprotein (wet weight; corresponding to 45 g dry weight) per day (equates to approx. 215 g Quorn Foods products, depending on the product)
Active Comparator: Meat/fish products
Standard meat/fish products matched to Quorn group for protein intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postabsorptive blood cholesterol (free, total, LDL, HDL) concentrations
Time Frame: 4 weeks
Test for intervention vs control differences in postabsorptive blood cholesterol levels (mMol) pre and post intervention
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial blood cholesterol concentration
Time Frame: 3 hours
Test for intervention vs control differences in postprandial blood cholesterol levels (mMol) pre and post intervention
3 hours
Fingerprick blood glucose concentration
Time Frame: 4 weeks
Test for intervention vs control differences in blood glucose concentration (mMol) in postabsorptive and postprandial state
4 weeks
Satiety
Time Frame: 4 weeks
Test for intervention vs control differences in satiety using a 10 centimetre 'Satiety Visual Analogue Scale' ratings, anchored by minimum to maximum response for a given aspect of satiety, where 0 cm is minimum and 10 cm is maximum
4 weeks
Hedonic visual analogue scale
Time Frame: 4 weeks
Test for intervention vs control differences and changes in hedonic response using 10 cm 'Hedonic Visual Analogue Scale' ratings, anchored by minimum to maximum response for a given aspect of hedonic response, where 0 cm is minimum and 10 cm is maximum
4 weeks
Gastrointestinal side-effects
Time Frame: Once weekly, over 4 weeks
Test for intervention vs control differences in tolerance of diet
Once weekly, over 4 weeks
Fingerprick blood c-peptide
Time Frame: 4 weeks
Test for intervention vs control differences in C-peptide concentration (ng/ml) in postabsorptive and postprandial state
4 weeks
Fingerprick blood triglyceride concentration
Time Frame: 4 weeks
Test for intervention vs control differences in blood triglyceride concentration (mMol) in postabsorptive and postprandial state
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Benjamin T Wall, PhD, University of Exeter

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 (Actual)

November 9, 2020

Primary Completion (Actual)

December 17, 2021

Study Completion (Actual)

December 17, 2021

Study Registration Dates

First Submitted

February 22, 2021

First Submitted That Met QC Criteria

February 25, 2021

First Posted (Actual)

February 26, 2021

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201021-B-02 Wall

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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