- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04773483
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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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