Brain Regulation of Appetite in Twins (BRAT)

October 25, 2017 updated by: Ellen Schur, MD, MS, University of Washington
Scientists are examining the genetic and environmental influences on appetite and weight gain. The main purpose of this study is to look at how genetic and environmental factors may influence how the brain regulates appetite and food intake. Understanding how the brain regulates appetite and food intake 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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.
122

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, 98195
        • University of Washington

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

Non-Probability Sample

Study Population

Monozygotic and dizygotic twins recruited from the University of Washington Twin Registry

Description

Inclusion Criteria:

  • Ability and willingness to come with their twin to the University of Washington (Seattle)
  • Additional Criteria for Aim 1 random sample only: Member of randomly selected MZ pair or
  • Additional criteria for Aim 2 random sample only: One member of MZ or same-sex DZ pair with BMI of at least 30 kg/m^2
  • Additional criteria for Aim 3 sample only: Member of randomly selected MZ pair, and not BMI discordant ≥ 5 kg/m^2

Exclusion Criteria:

  • History of weight loss surgery or active participation in weight loss program
  • Major medical problem (e.g., diabetes, cancer)
  • Current use of weight loss medications or other medications known to alter appetite
  • Pregnancy or menopause
  • MRI contraindication (i.e., implanted metal, claustrophobia)
  • Lifetime eating disorder
  • Current smoking
  • Current heavy alcohol use (≥2 drinks per day for females and ≥ 3 drinks per day for males)
  • Self-reported weight >330 pounds at time of phone screening. MRI cannot accommodate all shapes or weights. Inability to have MRI does not exclude subject from participating in other study procedures.
  • BMI < 18.5 or > 45 kg/m^2
  • Allergies to study foods or inability to taste
  • Twins were raised apart
  • Co-twin not eligible or not willing to participate

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: Family-Based
  • Time Perspectives: Prospective

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.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
27 Monozygotic Pairs
Device: Functional Magnetic Resonance Imaging
Measure brain activity.
Other Names:
  • fMRI
Radiation: Dual Energy X-ray absorptiometry
Body composition measurements.
Other Names:
  • DXA
Other: Questionnaires
Questionnaires related to: health, weight, sleep, mood, dietary habits, attitudes towards eating, how you describe yourself.
Other: Mood and Appetite Ratings
Answer questions about how you are feeling at the moment.
Other: Test Meals
Breakfast, a snack, and lunch provided during study visit.
Other: Computer Tests
Perform a series of computer tests to determine reaction time.
Procedure: Intravenous Catheter (IV) placement
Blood samples collected throughout regular intervals during the study visit day to measure levels of hormones involved in regulating appetite and body weight. We will also determine if twins are fraternal or identical and will examine DNA to see if participants carry two genes that affect appetite or body weight, the FTO gene and the MC4R gene.
27 Dizygotic Pairs
Device: Functional Magnetic Resonance Imaging
Measure brain activity.
Other Names:
  • fMRI
Radiation: Dual Energy X-ray absorptiometry
Body composition measurements.
Other Names:
  • DXA
Other: Questionnaires
Questionnaires related to: health, weight, sleep, mood, dietary habits, attitudes towards eating, how you describe yourself.
Other: Mood and Appetite Ratings
Answer questions about how you are feeling at the moment.
Other: Test Meals
Breakfast, a snack, and lunch provided during study visit.
Other: Computer Tests
Perform a series of computer tests to determine reaction time.
Procedure: Intravenous Catheter (IV) placement
Blood samples collected throughout regular intervals during the study visit day to measure levels of hormones involved in regulating appetite and body weight. We will also determine if twins are fraternal or identical and will examine DNA to see if participants carry two genes that affect appetite or body weight, the FTO gene and the MC4R gene.

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
Time Frame
Meal-induced nutrient and hormonal changes in plasma (insulin, GLP-1, ghrelin, glucose)
Time Frame: Baseline
Baseline
Brain activation during fMRI in satiety-related regions
Time Frame: Baseline
Baseline
Body composition: fasting leptin and dual energy X-ray absorptiometry (DXA)
Time Frame: Baseline
Baseline
DNA evaluation of FTO genotypes
Time Frame: Baseline
Baseline
Objective satiety: caloric and macronutrient intake
Time Frame: Baseline
Baseline
Subjective satiety: visual analog scale (VAS) scores and appeal ratings
Time Frame: Baseline
Baseline

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

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Columbia University
Fred Hutchinson Cancer Center

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, University of Washington

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

Helpful Links

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.
August 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.
August 1, 2015

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.
August 1, 2015

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 17, 2015

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 24, 2015

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 29, 2015

Study Record Updates

Last Update Posted (Actual)

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.
October 27, 2017

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.
October 25, 2017

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.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 38970 (Other Identifier: DAIDS DOCUMENT ID)

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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