AppetitemycoproteinNCT02053025
Appetite Regulation and Mycoprotein
A study testing mycoprotein in people with Appetite and Energy Intake, run by Imperial College London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetite, Energy Intake
- What is being tested?
- mycoprotein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2010to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Appetite, Energy Intake
- Being tested
- mycoprotein, control protein
- Keywords
- appetite, overweight, energy intake, obesity, gut hormones
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mycoproteinDietary supplement
control proteinDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| mycoprotein | Active comparator | 3 levels of mycoprotein will be consumed Receives: Dietary Supplement: mycoprotein |
| control protein | Active comparator | 3 levels of a control protein will be consumed Receives: Dietary Supplement: control protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy intake at ad-libitum meal
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.
Measured: upon completion of all participants, expected timeframe: 2 years
Secondary outcomes (2)
Glucagon-like peptide-1 (GLP-1)
Plasma glucagon-like peptide-1 (GLP-1) concentrations will be measured by radioimmunoassay (RIA) at the end of the study
Measured: upon completion of all participants, expected at 2 years
peptide tyrosine-tyrosine (PYY) levels
Plasma peptide tyrosine-tyrosine (PYY) concentrations will be measured by radioimmunoassay (RIA) at the end of the study
Measured: upon completion of all participants, expected at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startMar 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AppetiteStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary Frost, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053025
- Sponsor's protocol ID
- CRO1332
- Acronym
- mycoprotein
- Status last verified
- Oct 2019
- First submitted
- 22 Jan 2014
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bottin JH, Swann JR, Cropp E, Chambers ES, Ford HE, Ghatei MA, Frost GS. Mycoprotein reduces energy intake and postprandial insulin release without altering glucagon-like peptide-1 and peptide tyrosine-tyrosine concentrations in healthy overweight and obese adults: a randomised-controlled trial. Br J Nutr. 2016 Jul;116(2):360-74. doi: 10.1017/S0007114516001872. Epub 2016 May 20.
PubMed 27198187
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appetite Regulation and Mycoprotein
- ClinicalTrials.gov ID
- NCT02053025
- Acronym / sponsor ID
- mycoprotein / CRO1332
- Conditions
- Appetite, Energy Intake
- Keywords
- appetite, overweight, energy intake, obesity, gut hormones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Mar 2010 (actual)
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mycoprotein | Active comparator | Dietary Supplement: mycoprotein3 levels of mycoprotein will be consumed |
| control protein | Active comparator | Dietary Supplement: control protein3 levels of a control protein will be consumed |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mycoprotein | Dietary supplement | mycoprotein |
| control protein | Dietary supplement | control protein |
Primary outcome
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.
2 secondary outcomes
Glucagon-like peptide-1 (GLP-1)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Results publication: PubMed 27198187Bottin JH, Swann JR, Cropp E, Chambers ES, Ford HE, Ghatei MA, Frost GS. Mycoprotein reduces energy intake and postprandial insulin release without altering glucagon-like peptide-1 and peptide tyrosine-tyrosine concentrations in healthy overweight and obese adults: a randomised-controlled trial. Br J Nutr. 2016 Jul;116(2):360-74. doi: 10.1017/S0007114516001872. Epub 2016 May 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Frost principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mycoprotein in people with Appetite and Energy Intake, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy intake at ad-libitum meal (time frame: upon completion of all participants, expected timeframe: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02053025, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2019.