Quorn in Community Health Experiment

Study Overview
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Brief Summary
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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?

Official Title
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Quorn in Community Health Experiment

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Dietary Supplement: Quorn Foods products
* Dietary Supplement: Meat/fish products


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Quorn Food products<br> | Dietary Supplement: Quorn Foods products<br>* 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)<br>|
| Active Comparator: Meat/fish products<br> | Dietary Supplement: Meat/fish products<br>* Standard meat/fish products matched to Quorn group for protein intake<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postabsorptive blood cholesterol (free, total, LDL, HDL) concentrations | 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 | Test for intervention vs control differences in postprandial blood cholesterol levels (mMol) pre and post intervention | 3 hours | 
| Fingerprick blood glucose concentration | Test for intervention vs control differences in blood glucose concentration (mMol) in postabsorptive and postprandial state | 4 weeks | 
| 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 | 4 weeks | 
| 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 | 4 weeks | 
| Gastrointestinal side-effects | Test for intervention vs control differences in tolerance of diet | Once weekly, over 4 weeks | 
| Fingerprick blood c-peptide | Test for intervention vs control differences in C-peptide concentration (ng/ml) in postabsorptive and postprandial state | 4 weeks | 
| Fingerprick blood triglyceride concentration | Test for intervention vs control differences in blood triglyceride concentration (mMol) in postabsorptive and postprandial state | 4 weeks |