NCT04773483

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2021

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

February 22, 2021

Last Update Submit

March 21, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Postprandial blood cholesterol concentration

    3 hours

  • Fingerprick blood glucose concentration

    4 weeks

  • Satiety

    4 weeks

  • Hedonic visual analogue scale

    4 weeks

  • Gastrointestinal side-effects

    Once weekly, over 4 weeks

  • +2 more secondary outcomes

Study Arms (2)

Quorn Food products

ACTIVE COMPARATOR
Dietary Supplement: Quorn Foods products

Meat/fish products

ACTIVE COMPARATOR
Dietary Supplement: Meat/fish products

Interventions

Quorn Foods productsDIETARY_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)

Quorn Food products
Meat/fish productsDIETARY_SUPPLEMENT

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

Meat/fish products

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

Location

Related Publications (1)

  • Pavis GF, Iniesta RR, Roper H, Theobald HE, Derbyshire EJ, Finnigan TJA, Stephens FB, Wall BT. A four-week dietary intervention with mycoprotein-containing food products reduces serum cholesterol concentrations in community-dwelling, overweight adults: A randomised controlled trial. Clin Nutr. 2024 Mar;43(3):649-659. doi: 10.1016/j.clnu.2024.01.023. Epub 2024 Jan 24.

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Benjamin T Wall, PhD

    University of Exeter

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2021

First Posted

February 26, 2021

Study Start

November 9, 2020

Primary Completion

December 17, 2021

Study Completion

December 17, 2021

Last Updated

March 22, 2023

Record last verified: 2023-03

Locations