The Effect of a Meal on Brain Activation in Reward Pathways (Satiety)

• ClinicalTrials.gov Identifier: NCT01631045
• Recruitment Status: Completed
• First Posted: June 28, 2012
• Last Update Posted: July 4, 2013
• Sponsor: University of Washington
• Information provided by (Responsible Party): Ellen Schur, MD, MS, University of Washington

Study Description

Brief 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. 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.

Condition or disease
Brain Response to Visual Food Cues

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

• Study Type: Observational
• Actual Enrollment: 24 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: The Effect of a Meal on Brain Activation in Reward Pathways
• Study Start Date: April 2010
• Actual Primary Completion Date: June 2012
• Actual Study Completion Date: June 2012

Groups and Cohorts

Group/Cohort
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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Secondary endpoints are the amount of food eaten at a lunch buffet and self-reported appetite ratings. [ Time Frame: Every 30 minutes throughout study. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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.

Criteria

Inclusion Criteria:

1. Age 18-50

2. 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:

1. Current dieting for weight loss or restrained eating
2. History of eating disorders, prior obesity, or weight loss surgery
3. Chronic health conditions, including diabetes
4. Use of medications that alter appetite (e.g., atypical anti-psychotics)
5. Pregnancy or use of oral contraceptives of estrogen replacement
6. Participation in other studies that might affect appetite or body weight
7. Recreational drug use or alcohol use of >2 drinks per day
8. Food allergies to study foods or inability to taste
9. Current smoker

10. 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.

Contacts and Locations

Locations

United States, Washington

University of Washington Medical Center

Seattle, Washington, United States, 98104

Sponsors and Collaborators

University of Washington

Investigators

• Principal Investigator: Ellen Schur, MD, MS; Assistant Professor

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Ellen Schur, MD, MS, Assistant Professor, University of Washington
• ClinicalTrials.gov Identifier: NCT01631045
• Other Study ID Numbers: 38022
• First Posted: June 28, 2012
• Last Update Posted: July 4, 2013
• Last Verified: July 2013

Keywords provided by Ellen Schur, MD, MS, University of Washington:

Obesity