NCT02483663

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 29, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

5 years

First QC Date

June 17, 2015

Last Update Submit

October 25, 2017

Conditions

Keywords

TwinsObesityAppetite

Outcome Measures

Primary Outcomes (6)

  • Meal-induced nutrient and hormonal changes in plasma (insulin, GLP-1, ghrelin, glucose)

    Baseline

  • Brain activation during fMRI in satiety-related regions

    Baseline

  • Body composition: fasting leptin and dual energy X-ray absorptiometry (DXA)

    Baseline

  • DNA evaluation of FTO genotypes

    Baseline

  • Objective satiety: caloric and macronutrient intake

    Baseline

  • Subjective satiety: visual analog scale (VAS) scores and appeal ratings

    Baseline

Study Arms (2)

27 Monozygotic Pairs

Device: Functional Magnetic Resonance ImagingRadiation: Dual Energy X-ray absorptiometryOther: QuestionnairesOther: Mood and Appetite RatingsOther: Test MealsOther: Computer TestsProcedure: Intravenous Catheter (IV) placement

27 Dizygotic Pairs

Device: Functional Magnetic Resonance ImagingRadiation: Dual Energy X-ray absorptiometryOther: QuestionnairesOther: Mood and Appetite RatingsOther: Test MealsOther: Computer TestsProcedure: Intravenous Catheter (IV) placement

Interventions

Measure brain activity.

Also known as: fMRI
27 Dizygotic Pairs27 Monozygotic Pairs

Body composition measurements.

Also known as: DXA
27 Dizygotic Pairs27 Monozygotic Pairs

Questionnaires related to: health, weight, sleep, mood, dietary habits, attitudes towards eating, how you describe yourself.

27 Dizygotic Pairs27 Monozygotic Pairs

Answer questions about how you are feeling at the moment.

27 Dizygotic Pairs27 Monozygotic Pairs

Breakfast, a snack, and lunch provided during study visit.

27 Dizygotic Pairs27 Monozygotic Pairs

Perform a series of computer tests to determine reaction time.

27 Dizygotic Pairs27 Monozygotic Pairs

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 Pairs27 Monozygotic Pairs

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (3)

  • Melhorn SJ, Askren MK, Chung WK, Kratz M, Bosch TA, Tyagi V, Webb MF, De Leon MRB, Grabowski TJ, Leibel RL, Schur EA. FTO genotype impacts food intake and corticolimbic activation. Am J Clin Nutr. 2018 Feb 1;107(2):145-154. doi: 10.1093/ajcn/nqx029.

  • Mestre ZL, Melhorn SJ, Askren MK, Tyagi V, Gatenby C, Young L, Mehta S, Webb MF, Grabowski TJ, Schur EA. Effects of Anxiety on Caloric Intake and Satiety-Related Brain Activation in Women and Men. Psychosom Med. 2016 May;78(4):454-64. doi: 10.1097/PSY.0000000000000299.

  • Melhorn SJ, Mehta S, Kratz M, Tyagi V, Webb MF, Noonan CJ, Buchwald DS, Goldberg J, Maravilla KR, Grabowski TJ, Schur EA. Brain regulation of appetite in twins. Am J Clin Nutr. 2016 Feb;103(2):314-22. doi: 10.3945/ajcn.115.121095. Epub 2016 Jan 6.

Related Links

MeSH Terms

Conditions

Obesity

Interventions

Magnetic Resonance ImagingAbsorptiometry, PhotonSurveys and QuestionnairesDrug Implants

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographyDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthDelayed-Action PreparationsDosage FormsPharmaceutical Preparations

Study Officials

  • Ellen Schur, MD, MS

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Medicine

Study Record Dates

First Submitted

June 17, 2015

First Posted

June 29, 2015

Study Start

August 1, 2010

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

October 27, 2017

Record last verified: 2017-10

Locations