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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ellen Schur, MD, MS, University of Washington
ClinicalTrials.gov Identifier:
NCT01631045
First received: June 26, 2012
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

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
Brain Response to Visual Food Cues

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Effect of a Meal on Brain Activation in Reward Pathways

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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:
  • Secondary endpoints are the amount of food eaten at a lunch buffet and self-reported appetite ratings. [ Time Frame: Every 30 minutes throughout study. ] [ Designated as safety issue: No ]
    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.


Enrollment: 24
Study Start Date: April 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631045

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

No publications provided by University of Washington

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ellen Schur, MD, MS, Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01631045     History of Changes
Other Study ID Numbers: 38022
Study First Received: June 26, 2012
Last Updated: July 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Obesity

ClinicalTrials.gov processed this record on August 26, 2014