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Quorn in Community Health Experiment (QUICHE)

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Quorn Foods products
Meat/fish products
Sponsored by
University of Exeter
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight and Obesity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Exeter

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Quorn Food products

Meat/fish products

Arm Description

Outcomes

Primary Outcome Measures

Postabsorptive blood cholesterol (free, total, LDL, HDL) concentrations
Test for intervention vs control differences in postabsorptive blood cholesterol levels (mMol) pre and post intervention

Secondary Outcome Measures

Postprandial blood cholesterol concentration
Test for intervention vs control differences in postprandial blood cholesterol levels (mMol) pre and post intervention
Fingerprick blood glucose concentration
Test for intervention vs control differences in blood glucose concentration (mMol) in postabsorptive and postprandial state
Satiety
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
Hedonic visual analogue scale
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
Gastrointestinal side-effects
Test for intervention vs control differences in tolerance of diet
Fingerprick blood c-peptide
Test for intervention vs control differences in C-peptide concentration (ng/ml) in postabsorptive and postprandial state
Fingerprick blood triglyceride concentration
Test for intervention vs control differences in blood triglyceride concentration (mMol) in postabsorptive and postprandial state

Full Information

First Posted
February 22, 2021
Last Updated
March 21, 2023
Sponsor
University of Exeter
Collaborators
Marlow Foods Ltd, NIHR Exeter Clinical Research Facility
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1. Study Identification

Unique Protocol Identification Number
NCT04773483
Brief Title
Quorn in Community Health Experiment
Acronym
QUICHE
Official Title
Quorn in Community Health Experiment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 9, 2020 (Actual)
Primary Completion Date
December 17, 2021 (Actual)
Study Completion Date
December 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Exeter
Collaborators
Marlow Foods Ltd, NIHR Exeter Clinical Research Facility

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quorn Food products
Arm Type
Active Comparator
Arm Title
Meat/fish products
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Quorn Foods products
Intervention Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Meat/fish products
Intervention Description
Standard meat/fish products matched to Quorn group for protein intake
Primary Outcome Measure Information:
Title
Postabsorptive blood cholesterol (free, total, LDL, HDL) concentrations
Description
Test for intervention vs control differences in postabsorptive blood cholesterol levels (mMol) pre and post intervention
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Postprandial blood cholesterol concentration
Description
Test for intervention vs control differences in postprandial blood cholesterol levels (mMol) pre and post intervention
Time Frame
3 hours
Title
Fingerprick blood glucose concentration
Description
Test for intervention vs control differences in blood glucose concentration (mMol) in postabsorptive and postprandial state
Time Frame
4 weeks
Title
Satiety
Description
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
Time Frame
4 weeks
Title
Hedonic visual analogue scale
Description
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
Time Frame
4 weeks
Title
Gastrointestinal side-effects
Description
Test for intervention vs control differences in tolerance of diet
Time Frame
Once weekly, over 4 weeks
Title
Fingerprick blood c-peptide
Description
Test for intervention vs control differences in C-peptide concentration (ng/ml) in postabsorptive and postprandial state
Time Frame
4 weeks
Title
Fingerprick blood triglyceride concentration
Description
Test for intervention vs control differences in blood triglyceride concentration (mMol) in postabsorptive and postprandial state
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin T Wall, PhD
Organizational Affiliation
University of Exeter
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Exeter
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX1 2LU
Country
United Kingdom

12. IPD Sharing Statement

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Quorn in Community Health Experiment

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