QUICHE: Quorn in Community Health Experiment

• Sponsor: University of Exeter (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04773483
• Collaborator: Marlow Foods Ltd (Other), NIHR Exeter Clinical Research Facility (Other)
• Enrollment: 160
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 120
• Patients Per Site Per Month: 1.3

Study Details

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?

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity	Dietary Supplement: Quorn Foods products; Dietary Supplement: Meat/fish products	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 160 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: Nov 9, 2020
• Actual Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Nov 9, 2030

Arms and Interventions

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

Primary Outcome Measures

1. Postabsorptive blood cholesterol (free, total, LDL, HDL) concentrations [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 [3 hours]

   Test for intervention vs control differences in postprandial blood cholesterol levels (mMol) pre and post intervention

2. Fingerprick blood glucose concentration [4 weeks]

   Test for intervention vs control differences in blood glucose concentration (mMol) in postabsorptive and postprandial state

3. Satiety [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 [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 [Once weekly, over 4 weeks]

   Test for intervention vs control differences in tolerance of diet

6. Fingerprick blood c-peptide [4 weeks]

   Test for intervention vs control differences in C-peptide concentration (ng/ml) in postabsorptive and postprandial state

7. Fingerprick blood triglyceride concentration [4 weeks]

   Test for intervention vs control differences in blood triglyceride concentration (mMol) in postabsorptive and postprandial state

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Exeter	Exeter	Devon	United Kingdom	EX1 2LU

Sponsors and Collaborators

• University of Exeter
• Marlow Foods Ltd
• NIHR Exeter Clinical Research Facility

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Exeter
• ClinicalTrials.gov Identifier: NCT04773483
• Other Study ID Numbers: 201021-B-02 Wall
• First Posted: Feb 26, 2021
• Last Update Posted: May 27, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Overweight

Study Results

No Results Posted as of May 27, 2022