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Quorn in Community Health Experiment (QUICHE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04773483
Recruitment Status : Completed
First Posted : February 26, 2021
Last Update Posted : March 22, 2023
Sponsor:
Collaborators:
Marlow Foods Ltd
NIHR Exeter Clinical Research Facility
Information provided by (Responsible Party):
University of Exeter

Study Description
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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?

Condition or disease Intervention/treatment Phase
Overweight and Obesity Dietary Supplement: Quorn Foods products Dietary Supplement: Meat/fish products Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Quorn in Community Health Experiment
Actual Study Start Date : November 9, 2020
Actual Primary Completion Date : December 17, 2021
Actual Study Completion Date : December 17, 2021
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Quorn Food products 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)
Active Comparator: Meat/fish products Dietary Supplement: Meat/fish products
Standard meat/fish products matched to Quorn group for protein intake


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Postprandial blood cholesterol concentration [ Time Frame: 3 hours ]
    Test for intervention vs control differences in postprandial blood cholesterol levels (mMol) pre and post intervention

  2. Fingerprick blood glucose concentration [ Time Frame: 4 weeks ]
    Test for intervention vs control differences in blood glucose concentration (mMol) in postabsorptive and postprandial state

  3. 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. 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

  5. Gastrointestinal side-effects [ Time Frame: Once weekly, over 4 weeks ]
    Test for intervention vs control differences in tolerance of diet

  6. 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

  7. Fingerprick blood triglyceride concentration [ Time Frame: 4 weeks ]
    Test for intervention vs control differences in blood triglyceride concentration (mMol) in postabsorptive and postprandial state


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04773483


Locations
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United Kingdom
University of Exeter
Exeter, Devon, United Kingdom, EX1 2LU
Sponsors and Collaborators
University of Exeter
Marlow Foods Ltd
NIHR Exeter Clinical Research Facility
Investigators
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Principal Investigator: Benjamin T Wall, PhD University of Exeter
More Information
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Responsible Party: University of Exeter
ClinicalTrials.gov Identifier: NCT04773483    
Other Study ID Numbers: 201021-B-02 Wall
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: March 22, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Overnutrition
Nutrition Disorders
Body Weight