FastingNCT01721187
Satiety Effects on the Neural Valuation of Food
An observational study of Fasting and Fed, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
Trial summary
Using fMRI, this study will explore the neural correlates of satiety when individuals make decisions about food. The investigators will also examine individual differences in satiety effects. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2012to Jul 2014
- Phase
- Observational
- 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Community sample
Who may be able to join
- Chinese ethnicity
- 21 to 45 years old
- English as first language
- Right-handed
- Have normal eyesight, or have long-sightedness or myopia within +8.0 to -8.0 diopters (unless corrected by contact lenses)
- Weigh less than 100kg with an abdominal circumference of less than 120cm
Show all 10Show fewer
- Non-smoker, or only smoke occasionally (less than 5 sticks a week)
- Consume less than 2 units (200 mg) of caffeine a day
- Consume less than 21 units of alcohol per week (e.g. 500ml 5% beer = 2.5 units, 250ml 14% wine = 3.5 unit)
- Habitually sleep before 1am and wake before 9am
Who cannot join
- On a restrictive diet (e.g., vegetarian/vegan diet)
- History of food allergies
- History of psychiatric or neurological disorders
- History of chronic medical illness
- Metal implants in or on the body (e.g. braces, dental retainers, pacemakers)
- Shift worker
Show all 9Show fewer
- Claustrophobic
- High astigmatism (high = >2.00 diopters)
- Colour-blind
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Centre for Cognitive Neuroscience scanner suite
Singapore, Singapore, 169611
About this study
Official title: Functional Magnetic Resonance Imaging Study of the Valuation of Food as a Function of Satiety
Using fMRI, this study will explore the neural correlates of satiety when individuals make decisions about food. The investigators will also examine individual differences in satiety effects.
- Keywords
- fMRI, Satiety, Willingness to Pay, Incentive Delay, Dietary Disinhibition
- Medical subject headings
- Fasting, Lecithin Cholesterol Acyltransferase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low disinhibition | fMRI during fed and fasted states | |
| High disinhibition | fMRI during fed and fasted states |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI - Willingness to Pay task (BDM auction)
A measurement of how much participants are willing to pay for foods and non-foods, as an assay for subjective value of goods.
Measured: Fed and fasted visits (Wks 1 & 2)
fMRI - Monetary and Food Incentive Delay task
A measurement of neural response to anticipating and receiving money and food rewards.
Measured: Fed and fasted visits (Wks 1 & 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FastingStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke-NUS Graduate Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Human Development and Potential (IHDP), Singapore
- Responsible party
- Principal investigator, MChee, Duke-NUS Graduate Medical School
- Investigators
- Michael WL Chee, MBBS, Principal investigator, Duke-NUS Graduate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721187
- Sponsor's protocol ID
- VOFIO3G
- Status last verified
- Aug 2015
- First submitted
- 23 Oct 2012
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Plassmann H, O'Doherty J, Rangel A. Orbitofrontal cortex encodes willingness to pay in everyday economic transactions. J Neurosci. 2007 Sep 12;27(37):9984-8. doi: 10.1523/JNEUROSCI.2131-07.2007.
PubMed 17855612Knutson B, Westdorp A, Kaiser E, Hommer D. FMRI visualization of brain activity during a monetary incentive delay task. Neuroimage. 2000 Jul;12(1):20-7. doi: 10.1006/nimg.2000.0593.
PubMed 10875899
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Magnetic Resonance Imaging Study of the Valuation of Food as a Function of Satiety
- ClinicalTrials.gov ID
- NCT01721187
- Acronym / sponsor ID
- VOFIO3G
- Keywords
- fMRI, Satiety, Willingness to Pay, Incentive Delay, Dietary Disinhibition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Duke-NUS Graduate Medical SchoolUniversity, hospital or other
- Collaborators
- Institute for Human Development and Potential (IHDP), Singapore
- Study start
- Oct 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 5 Nov 2012 (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.
Using fMRI, this study will explore the neural correlates of satiety when individuals make decisions about food. The investigators will also examine individual differences in satiety effects.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low disinhibition | – | –fMRI during fed and fasted states |
| High disinhibition | – | –fMRI during fed and fasted states |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample
Key inclusion criteria (10 listed)
- Chinese ethnicity
- 21 to 45 years old
- English as first language
- Right-handed
- Have normal eyesight, or have long-sightedness or myopia within +8.0 to -8.0 diopters (unless corrected by contact lenses)
Key exclusion criteria (9 listed)
- On a restrictive diet (e.g., vegetarian/vegan diet)
- History of food allergies
- History of psychiatric or neurological disorders
- History of chronic medical illness
- Metal implants in or on the body (e.g. braces, dental retainers, pacemakers)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
fMRI - Willingness to Pay task (BDM auction)
Time frame: Fed and fasted visits (Wks 1 & 2)
A measurement of how much participants are willing to pay for foods and non-foods, as an assay for subjective value of goods.
fMRI - Monetary and Food Incentive Delay task
Time frame: Fed and fasted visits (Wks 1 & 2)
A measurement of neural response to anticipating and receiving money and food rewards.
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 5 Aug 2015.
- Background: PubMed 17855612Plassmann H, O'Doherty J, Rangel A. Orbitofrontal cortex encodes willingness to pay in everyday economic transactions. J Neurosci. 2007 Sep 12;27(37):9984-8. doi: 10.1523/JNEUROSCI.2131-07.2007.
- Background: PubMed 10875899Knutson B, Westdorp A, Kaiser E, Hommer D. FMRI visualization of brain activity during a monetary incentive delay task. Neuroimage. 2000 Jul;12(1):20-7. doi: 10.1006/nimg.2000.0593.
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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.
Michael WL Chee, MBBS principal investigator
Duke-NUS Graduate Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fasting and Fed, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
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 10 inclusion and 9 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 5 Aug 2015. 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 Singapore. 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?
fMRI - Willingness to Pay task (BDM auction) (time frame: Fed and fasted visits (Wks 1 & 2)). The study lists 2 primary outcomes in all. 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 NCT01721187, which also lists 2 linked publications.
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 5 Aug 2015.