AppetiteNCT02298049
An fMRI Study of Satiation in Healthy Volunteers.
A study testing Satiated / Pre-meal and MRI in people with Appetite, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
To our knowledge no study has assessed the effects of a meal on neural responses to food cues and compared this with a condition simulating natural inter-meal hunger levels. This is important, as the existing literature often compares the effect of fasting to satiation, which may not reflect typical appetite… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetite
- What is being tested?
- Satiated / Pre-meal and MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2010to Dec 2010
- 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
- Healthy volunteers
- Sufficiently fluent in English to understand the task and the instructions
Who cannot join
- Currently taking medication
- Past or current depression/dieting,
- Smokers
- Food allergies
- Diabetes
- Pregnancy
- BMI score outside the normal range
- Any contraindications to fMRI scanning (e.g. pacemakers, mechanical heart valve, hip replacement, metal implants)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Birmingham
Birmingham, West Midlands, B15 2TT
About this study
Official title: Satiation Attenuates BOLD Activity in Brain Regions Involved in Reward and Increases Activity in an Inhibitory Control Area: an fMRI Study in Healthy Volunteers.
To our knowledge no study has assessed the effects of a meal on neural responses to food cues and compared this with a condition simulating natural inter-meal hunger levels. This is important, as the existing literature often compares the effect of fasting to satiation, which may not reflect typical appetite processes. Thus, the purpose of this research was to examine the effect of a satiating lunch compared to a normal pre-meal state on blood oxygen level dependent (BOLD) activity in the human brain, as measured using functional magnetic resonance imaging (fMRI).
Read the detailed description
We hypothesized that satiation would be associated with decreased brain activity across brain regions involved in both appetite and reward such as ventromedial prefrontal cortex, orbitofrontal cortex, ventral striatum, hypothalamus, insula, amygdala and hippocampus. 16 healthy participants (8 males) were scanned on two separate test days, before and after eating a meal to satiation, or after not eating for 4 hours (satiated vs. pre-meal). fMRI BOLD signals to the sight and/or taste of the stimuli were recorded. Participants were given questionnaires to complete about their mood state and appetite before and after all scans.
- Conditions
- Appetite
- Being tested
- Satiated / Pre-meal, MRI
- Keywords
- fMRI, reward, satiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Satiated / Pre-mealOther
All participants were scanned before and after not being fed (pre-meal), and before and after being given a satiating lunch (satiated).
MRIDevice
| Study group | Role | What they receive |
|---|---|---|
| Scanning | Other | Repeated measures:
Satiation scan + Pre-meal scan
All participants undertook both scans Receives: Other: Satiated / Pre-meal; Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activation differences between satiated and pre-meal scan fMRI BOLD signal
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startJul 2010
- Primary completionDec 2010
- Study completionDec 2010
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Sponsor
- Investigators
- Jason M Thomas, MRes, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298049
- Sponsor's protocol ID
- UBirmingham
- Status last verified
- Nov 2014
- First submitted
- 19 Nov 2014
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Thomas JM, Higgs S, Dourish CT, Hansen PC, Harmer CJ, McCabe C. Satiation attenuates BOLD activity in brain regions involved in reward and increases activity in dorsolateral prefrontal cortex: an fMRI study in healthy volunteers. Am J Clin Nutr. 2015 Apr;101(4):697-704. doi: 10.3945/ajcn.114.097543. Epub 2015 Jan 21.
PubMed 25833968
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satiation Attenuates BOLD Activity in Brain Regions Involved in Reward and Increases Activity in an Inhibitory Control Area: an fMRI Study in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT02298049
- Acronym / sponsor ID
- UBirmingham
- Conditions
- Appetite
- Keywords
- fMRI, reward, satiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- Jul 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 21 Nov 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.
To our knowledge no study has assessed the effects of a meal on neural responses to food cues and compared this with a condition simulating natural inter-meal hunger levels. This is important, as the existing literature often compares the effect of fasting to satiation, which may not reflect typical appetite processes. Thus, the purpose of this research was to examine the effect of a satiating lunch compared to a normal pre-meal state on blood oxygen level dependent (BOLD) activity in the human brain, as measured using functional magnetic resonance imaging (fMRI).
Detailed description
We hypothesized that satiation would be associated with decreased brain activity across brain regions involved in both appetite and reward such as ventromedial prefrontal cortex, orbitofrontal cortex, ventral striatum, hypothalamus, insula, amygdala and hippocampus. 16 healthy participants (8 males) were scanned on two separate test days, before and after eating a meal to satiation, or after not eating for 4 hours (satiated vs. pre-meal). fMRI BOLD signals to the sight and/or taste of the stimuli were recorded. Participants were given questionnaires to complete about their mood state and appetite before and after all scans.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scanning | Other | Other: Satiated / Pre-meal, Device: MRIRepeated measures: Satiation scan + Pre-meal scan All participants undertook both scans |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers
- Sufficiently fluent in English to understand the task and the instructions
Key exclusion criteria (8 listed)
- Currently taking medication
- Past or current depression/dieting,
- Smokers
- Food allergies
- Diabetes
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 |
|---|---|---|
| Satiated / Pre-mealAll participants were scanned before and after not being fed (pre-meal), and before and after being given a satiating lunch (satiated). | Other | Scanning |
| MRI | Device | Scanning |
Primary outcome
Activation differences between satiated and pre-meal scan fMRI BOLD signal
Time frame: 6 months
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 21 Nov 2014.
- Derived from this study: PubMed 25833968Thomas JM, Higgs S, Dourish CT, Hansen PC, Harmer CJ, McCabe C. Satiation attenuates BOLD activity in brain regions involved in reward and increases activity in dorsolateral prefrontal cortex: an fMRI study in healthy volunteers. Am J Clin Nutr. 2015 Apr;101(4):697-704. doi: 10.3945/ajcn.114.097543. Epub 2015 Jan 21.
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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.
Jason M Thomas, MRes principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Satiated / Pre-meal and MRI in people with Appetite, run by University of Birmingham 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 2 inclusion and 8 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 21 Nov 2014. 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?
Activation differences between satiated and pre-meal scan fMRI BOLD signal (time frame: 6 months). 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 NCT02298049, 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 21 Nov 2014.