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Completed

NCT Number: NCT04773483

Quorn in Community Health Experiment

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?

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quorn Foods products

Dietary Supplement

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)

Meat/fish products

Dietary Supplement

Standard meat/fish products matched to Quorn group for protein intake

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Collaborators

  • Marlow Foods Ltd
  • NIHR Exeter Clinical Research Facility

Registry information

Acronym: QUICHE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 26, 2021
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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