Appetite Regulation and Mycoprotein (mycoprotein)

October 14, 2019 updated by: Imperial College London
The purpose of this study is to investigate the effect of eating various levels of mycoprotein (Quorn) on feelings of appetite, energy intake and levels of gut hormones in overweight volunteers.

Study Overview

Detailed Description

Owing to its relatively high protein and fibre content, mycoprotein presents an attractive food product to improve appetite regulation and postprandial glycaemic and insulin responses in overweight and obese individuals at risk of developing T2DM

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • London, United Kingdom, W12 0NN
        • Imperial College NIHR CRF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females between the ages of 18 and 65
  • body mass index (BMI) 25-32kg/m2
  • Weight stable over the past 6 months
  • No known major illness or eating disorder nor on any medication that may impact on appetite or hormone levels.
  • No paracetamol or other analgesic in the previous 48 hours
  • A score of <2.5 in the Dutch Eating Behaviour Questionnaire (DEBQ)
  • A score of <2 in the SCOFF questionnaire

Exclusion Criteria:

  • Persons outside the age and BMI ranges stated above
  • Pregnant and lactating women
  • Weight variation of greater than 5% in the last 6 months
  • Any diagnosed major illness
  • Any paracetamol or analgesic intake in the last 48 hours
  • Diagnosed eating disorder
  • Allergy to mycoprotein or mushrooms
  • Regular consumption of Quorn products
  • Dislike of any of the test foods or drinks
  • A score of >2.5 in the Dutch Eating Behaviour questionnaire
  • A score of 2 or more in the SCOFF questionaire

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: mycoprotein
3 levels of mycoprotein will be consumed
Active Comparator: control protein
3 levels of a control protein will be consumed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Energy intake at ad-libitum meal
Time Frame: upon completion of all participants, expected timeframe: 2 years
Energy intake will be assessed during an ad-libitum meal at 180 minutes at the end of each study visit. Participants will be offered a meal in excess and asked to eat until they feel comfortably full. The meal will be weighed before and after consumption and energy intake will be calculated from the manufacturer's reported nutritional composition.
upon completion of all participants, expected timeframe: 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucagon-like peptide-1 (GLP-1)
Time Frame: upon completion of all participants, expected at 2 years
Plasma glucagon-like peptide-1 (GLP-1) concentrations will be measured by radioimmunoassay (RIA) at the end of the study
upon completion of all participants, expected at 2 years
peptide tyrosine-tyrosine (PYY) levels
Time Frame: upon completion of all participants, expected at 2 years
Plasma peptide tyrosine-tyrosine (PYY) concentrations will be measured by radioimmunoassay (RIA) at the end of the study
upon completion of all participants, expected at 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Gary Frost, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2010

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

January 22, 2014

First Submitted That Met QC Criteria

January 31, 2014

First Posted (Estimate)

February 3, 2014

Study Record Updates

Last Update Posted (Actual)

October 16, 2019

Last Update Submitted That Met QC Criteria

October 14, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • CRO1332

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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