Brain Response to Visual Food CuesSatietyNCT01631045
The Effect of a Meal on Brain Activation in Reward Pathways
An observational study of Brain Response to Visual Food Cues, run by University of Washington at 1 site in United States.
Trial summary
Scientists have studied how fasting and nutrients affect brain function in animals. The purpose of this study is to look at the effects of both fasting and food intake on brain function and memory in humans. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Response to Visual Food Cues
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jun 2012
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: We will enroll 21 healthy subjects. Participants will be recruited by flyers posted at the University and by newspaper advertisements.
Who may be able to join
- Age 18-50
- Body mass index (BMI) 18.5-24.9 kg/m2
- Age and weight are restricted because of known changes in appetite and satiety with aging and changes in body weight.
Who cannot join
- Current dieting for weight loss or restrained eating
- History of eating disorders, prior obesity, or weight loss surgery
- Chronic health conditions, including diabetes
- Use of medications that alter appetite (e.g., atypical anti-psychotics)
- Pregnancy or use of oral contraceptives of estrogen replacement
- Participation in other studies that might affect appetite or body weight
Show all 11Show fewer
- Recreational drug use or alcohol use of >2 drinks per day
- Food allergies to study foods or inability to taste
- Current smoker
- Any contraindications to MRI such as implanted metal of claustrophobia
- Current dieting, restrained eating, eating disorders, prior weight loss surgery, diabetes, chronic disease (e.g., cardiovascular disease, cancer), and estrogen use are restricted or excluded due to documented influences on the hormones of interest. Smokers and regular alcohol users are excluded consistent with prior studies of appetite regulation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Medical Center
Seattle, Washington, 98104
About this study
Scientists have studied how fasting and nutrients affect brain function in animals. The purpose of this study is to look at the effects of both fasting and food intake on brain function and memory in humans. To do this the investigators will use functional MRI to observe the brain and its function while fasting and after a meal. Understanding the action of these hormones in the brain may eventually lead to new ways to help people avoid obesity or lose weight.
Read the detailed description
Potential subjects will participate in a short phone screening interview and if eligible, will come to the University of Washington hospital 2 times. At the first health screening visit, we will go over the subjects' medical history, weight and height, and eating habits. This visit will take an hour or so and eligible subjects will then schedule the study visit. For the study visit, subjects will have to fast overnight from 9:30 pm the night before and arrive at the hospital at 8:00am. At 8:30 am, the subject will have a 30 minute MRI scan of the brain done in the University of Washington Radiology Department. During the MRI scan they will see pictures of common objects and foods and be asked to remember the photos they saw. At 9 am subjects will eat a standard breakfast, and they will not eat again until after the second MRI. The time of their second MRI will be randomly assigned to one of seven time points anywhere from 15 minutes to 5 hours after the breakfast. After the MRI, subjects will be allowed to eat freely from food we provide. Subjects will receive $10 for the health screening visit, and $50-85 depending on the length of the visit.
- Conditions
- Brain Response to Visual Food Cues
- Keywords
- Obesity
- Medical subject headings
- Obesity
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 |
|---|---|---|
| 15 min | Subjects post-meal brain MRI will be 15 minutes after breakfast. | |
| 30 min | Subjects post-meal brain MRI will be 30 minutes after breakfast. | |
| 60 | Subjects post-meal brain MRI will be 60 minutes after breakfast. | |
| 120 | Subjects post-meal brain MRI will be 120 minutes after breakfast. | |
| 180 | Subjects post-meal brain MRI will be 180 minutes after breakfast. | |
| 240 | Subjects post-meal brain MRI will be 240 minutes after breakfast. | |
| 300 | Subjects post-meal brain MRI will be 300 minutes after breakfast. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD response as measured by brain fMRI during viewing of food photographs
To determine whether the change in brain response (as captured by MRI) to visual food cues with food intake is a marker of satiety. We hypothesize that consumption of a meal will reduce brain activation by food cues and that these reductions will be temporally associated with both subjective and objective measures of satiety.
Measured: We will randomly assign subjects to one of 7 timepoints for a post-meal brain MRI - 15, 30, 60, 120, 180, 240, or 300 minutes after their breakfast.
Secondary outcomes (1)
Secondary endpoints are the amount of food eaten at a lunch buffet and self-reported appetite ratings.
To measure subjective appetite and satiety, subjects will complete serial visual analog rating scales (VAS) of hunger and fullness every 30 minutes. We predict that the percentage change in brain activation will correlate with changes in self-reported hunger and fullness. After the post-meal scan, we will obtain measurements of objective satiety for each subject by monitoring his or her food intake during a 30 minute ad libitum buffet meal. The buffet will be surreptitiously monitored, allowing us to assess ad libitum caloric intake and food choices.
Measured: Every 30 minutes throughout study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startApr 2010
- Primary completionJun 2012
- Study completionJun 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 Brain Response to Visual Food CuesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen Schur, MD, MS, University of Washington
- Investigators
- Ellen Schur, MD, MS, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631045
- Sponsor's protocol ID
- 38022
- Acronym
- Satiety
- Status last verified
- Jul 2013
- First submitted
- 26 Jun 2012
- Last updated
- 4 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mehta S, Melhorn SJ, Smeraglio A, Tyagi V, Grabowski T, Schwartz MW, Schur EA. Regional brain response to visual food cues is a marker of satiety that predicts food choice. Am J Clin Nutr. 2012 Nov;96(5):989-99. doi: 10.3945/ajcn.112.042341. Epub 2012 Sep 18.
PubMed 22990034
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Meal on Brain Activation in Reward Pathways
- ClinicalTrials.gov ID
- NCT01631045
- Acronym / sponsor ID
- Satiety / 38022
- Conditions
- Brain Response to Visual Food Cues
- Keywords
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 28 Jun 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.
Scientists have studied how fasting and nutrients affect brain function in animals. The purpose of this study is to look at the effects of both fasting and food intake on brain function and memory in humans. To do this the investigators will use functional MRI to observe the brain and its function while fasting and after a meal. Understanding the action of these hormones in the brain may eventually lead to new ways to help people avoid obesity or lose weight.
Detailed description
Potential subjects will participate in a short phone screening interview and if eligible, will come to the University of Washington hospital 2 times. At the first health screening visit, we will go over the subjects' medical history, weight and height, and eating habits. This visit will take an hour or so and eligible subjects will then schedule the study visit. For the study visit, subjects will have to fast overnight from 9:30 pm the night before and arrive at the hospital at 8:00am. At 8:30 am, the subject will have a 30 minute MRI scan of the brain done in the University of Washington Radiology Department. During the MRI scan they will see pictures of common objects and foods and be asked to remember the photos they saw. At 9 am subjects will eat a standard breakfast, and they will not eat again until after the second MRI. The time of their second MRI will be randomly assigned to one of seven time points anywhere from 15 minutes to 5 hours after the breakfast. After the MRI, subjects will be allowed to eat freely from food we provide. Subjects will receive $10 for the health screening visit, and $50-85 depending on the length of the visit.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 15 min | – | –Subjects post-meal brain MRI will be 15 minutes after breakfast. |
| 30 min | – | –Subjects post-meal brain MRI will be 30 minutes after breakfast. |
| 60 | – | –Subjects post-meal brain MRI will be 60 minutes after breakfast. |
| 120 | – | –Subjects post-meal brain MRI will be 120 minutes after breakfast. |
| 180 | – | –Subjects post-meal brain MRI will be 180 minutes after breakfast. |
| 240 | – | –Subjects post-meal brain MRI will be 240 minutes after breakfast. |
| 300 | – | –Subjects post-meal brain MRI will be 300 minutes after breakfast. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- We will enroll 21 healthy subjects. Participants will be recruited by flyers posted at the University and by newspaper advertisements.
Key inclusion criteria (3 listed)
- Age 18-50
- Body mass index (BMI) 18.5-24.9 kg/m2
Key exclusion criteria (11 listed)
- Current dieting for weight loss or restrained eating
- History of eating disorders, prior obesity, or weight loss surgery
- Chronic health conditions, including diabetes
- Use of medications that alter appetite (e.g., atypical anti-psychotics)
- Pregnancy or use of oral contraceptives of estrogen replacement
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
BOLD response as measured by brain fMRI during viewing of food photographs
Time frame: We will randomly assign subjects to one of 7 timepoints for a post-meal brain MRI - 15, 30, 60, 120, 180, 240, or 300 minutes after their breakfast.
To determine whether the change in brain response (as captured by MRI) to visual food cues with food intake is a marker of satiety. We hypothesize that consumption of a meal will reduce brain activation by food cues and that these reductions will be temporally associated with both subjective and objective measures of satiety.
1 secondary outcome
Secondary endpoints are the amount of food eaten at a lunch buffet and self-reported appetite ratings.
Time frame: Every 30 minutes throughout study.
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 4 Jul 2013.
- Derived from this study: PubMed 22990034Mehta S, Melhorn SJ, Smeraglio A, Tyagi V, Grabowski T, Schwartz MW, Schur EA. Regional brain response to visual food cues is a marker of satiety that predicts food choice. Am J Clin Nutr. 2012 Nov;96(5):989-99. doi: 10.3945/ajcn.112.042341. Epub 2012 Sep 18.
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.
Ellen Schur, MD, MS principal investigator
Assistant Professor
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 Brain Response to Visual Food Cues, run by University of Washington at 1 site in United States.
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 3 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 4 Jul 2013. 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 States. 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?
BOLD response as measured by brain fMRI during viewing of food photographs (time frame: We will randomly assign subjects to one of 7 timepoints for a post-meal brain MRI - 15, 30, 60, 120, 180, 240, or 300 minutes after their breakfast.). 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 NCT01631045, 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 4 Jul 2013.