- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01631045
The Effect of a Meal on Brain Activation in Reward Pathways (Satiety)
July 2, 2013 updated by: Ellen Schur, MD, MS, University of Washington
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
24
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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Washington
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Seattle, Washington, United States, 98104
- University of Washington Medical Center
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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 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
We will enroll 21 healthy subjects.
Participants will be recruited by flyers posted at the University and by newspaper advertisements.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
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
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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15 min
Subjects post-meal brain MRI will be 15 minutes after breakfast.
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30 min
Subjects post-meal brain MRI will be 30 minutes after breakfast.
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60
Subjects post-meal brain MRI will be 60 minutes after breakfast.
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120
Subjects post-meal brain MRI will be 120 minutes after breakfast.
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180
Subjects post-meal brain MRI will be 180 minutes after breakfast.
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240
Subjects post-meal brain MRI will be 240 minutes after breakfast.
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300
Subjects post-meal brain MRI will be 300 minutes after breakfast.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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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.
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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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Secondary endpoints are the amount of food eaten at a lunch buffet and self-reported appetite ratings.
Time Frame: Every 30 minutes throughout study.
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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.
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Every 30 minutes throughout study.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ellen Schur, MD, MS, Assistant Professor
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
April 1, 2010
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
June 26, 2012
First Submitted That Met QC Criteria
June 27, 2012
First Posted (Estimate)
June 28, 2012
Study Record Updates
Last Update Posted (Estimate)
July 4, 2013
Last Update Submitted That Met QC Criteria
July 2, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 38022
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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