Overweight and Obesity Clinical Trial
— QUICHEOfficial title:
Quorn in Community Health Experiment
| Verified date | March 2023 |
| Source | University of Exeter |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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?
| Status | Completed |
| Enrollment | 82 |
| Est. completion date | December 17, 2021 |
| Est. primary completion date | December 17, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | University of Exeter | Exeter | Devon |
| Lead Sponsor | Collaborator |
|---|---|
| University of Exeter | Marlow Foods Ltd, NIHR Exeter Clinical Research Facility |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Postprandial blood cholesterol concentration | Test for intervention vs control differences in postprandial blood cholesterol levels (mMol) pre and post intervention | 3 hours | |
| Secondary | Fingerprick blood glucose concentration | Test for intervention vs control differences in blood glucose concentration (mMol) in postabsorptive and postprandial state | 4 weeks | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Gastrointestinal side-effects | Test for intervention vs control differences in tolerance of diet | Once weekly, over 4 weeks | |
| Secondary | Fingerprick blood c-peptide | Test for intervention vs control differences in C-peptide concentration (ng/ml) in postabsorptive and postprandial state | 4 weeks | |
| Secondary | Fingerprick blood triglyceride concentration | Test for intervention vs control differences in blood triglyceride concentration (mMol) in postabsorptive and postprandial state | 4 weeks |
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