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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington Medical Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  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.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Every 30 minutes throughout study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 4, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 38022

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