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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

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

University of Washington

Collaborators

Columbia University
Fred Hutchinson Cancer Center

Investigators

  • 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

August 1, 2010

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

June 17, 2015

First Submitted That Met QC Criteria

June 24, 2015

First Posted (Estimate)

June 29, 2015

Study Record Updates

Last Update Posted (Actual)

October 27, 2017

Last Update Submitted That Met QC Criteria

October 25, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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