- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02053025
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
Status
Completed
Conditions
Intervention / Treatment
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
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London, United Kingdom, W12 0NN
- Imperial College NIHR CRF
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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 |
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Active Comparator: mycoprotein
3 levels of mycoprotein will be consumed
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Active Comparator: control protein
3 levels of a control protein will be consumed
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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.
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upon completion of all participants, expected timeframe: 2 years
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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
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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
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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.
Sponsor
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
Keywords
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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