Quorn in Community Health Experiment (QUICHE)

• ClinicalTrials.gov Identifier: NCT04773483
• Recruitment Status: Completed
• First Posted: February 26, 2021
• Last Update Posted: March 22, 2023
• Sponsor: University of Exeter
• Collaborators: Marlow Foods Ltd; NIHR Exeter Clinical Research Facility
• Information provided by (Responsible Party): University of Exeter

Tracking Information

• First Submitted Date: February 22, 2021
• First Posted Date: February 26, 2021
• Last Update Posted Date: March 22, 2023
• Actual Study Start Date: November 9, 2020
• Actual Primary Completion Date: December 17, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 8, 2021)

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

Original Primary Outcome Measures (submitted: February 25, 2021)

Postabsorptive blood cholesterol (free, total, LDL, HDL) concentrations [ Time Frame: 4 weeks ]

Test for intervention vs control differences in postabsorptive blood cholesterol levels pre and post intervention

Current Secondary Outcome Measures (submitted: March 8, 2021)

• Postprandial blood cholesterol concentration [ Time Frame: 3 hours ]
  Test for intervention vs control differences in postprandial blood cholesterol levels (mMol) pre and post intervention
• Fingerprick blood glucose concentration [ Time Frame: 4 weeks ]
  Test for intervention vs control differences in blood glucose concentration (mMol) in postabsorptive and postprandial state
• 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
• 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
• Gastrointestinal side-effects [ Time Frame: Once weekly, over 4 weeks ]
  Test for intervention vs control differences in tolerance of diet
• 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
• Fingerprick blood triglyceride concentration [ Time Frame: 4 weeks ]
  Test for intervention vs control differences in blood triglyceride concentration (mMol) in postabsorptive and postprandial state

Original Secondary Outcome Measures (submitted: February 25, 2021)

• Postprandial blood cholesterol concentration [ Time Frame: 3 hours ]
  Test for intervention vs control differences in postprandial blood cholesterol levels pre and post intervention
• Exploratory blood metabolites [ Time Frame: 4 weeks ]
  Test for intervention vs control differences in various other exploratory blood markers of metabolic health (e.g. glucose, c-peptide, lipid profiles etc.)
• Satiety [ Time Frame: Once weekly, over 4 weeks ]
  Test for intervention vs control differences in satiety using a validated questionnaire comprising of multiple visual analogue scales, anchored by minimum to maximum response for a given aspect of satiety
• Sensory [ Time Frame: Once weekly, over 4 weeks ]
  Test for intervention vs control differences and changes in sensory analysis using a validated questionnaire comprising of multiple visual analogue scales, anchored by minimum to maximum response for a given aspect of sensory experience
• Gastrointestinal side-effects [ Time Frame: Twice weekly, over 4 weeks ]
  Test for intervention vs control differences in tolerance of diet

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Quorn in Community Health Experiment
• Official Title: Quorn in Community Health Experiment
• 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?
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Overweight and Obesity

Intervention

• Dietary Supplement: Quorn Foods 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)
• Dietary Supplement: Meat/fish products
  Standard meat/fish products matched to Quorn group for protein intake

Study Arms

• Active Comparator: Quorn Food products
  Intervention: Dietary Supplement: Quorn Foods products
• Active Comparator: Meat/fish products
  Intervention: Dietary Supplement: Meat/fish products

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 21, 2023): 82
• Original Estimated Enrollment (submitted: February 25, 2021): 160
• Actual Study Completion Date: December 17, 2021
• Actual Primary Completion Date: December 17, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT04773483
• Other Study ID Numbers: 201021-B-02 Wall
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Exeter
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Exeter
• Original Study Sponsor: Same as current

Collaborators

• Marlow Foods Ltd
• NIHR Exeter Clinical Research Facility

Investigators

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

• PRS Account: University of Exeter
• Verification Date: March 2023