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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02483663
Other study ID # 38970
Secondary ID
Status Completed
Phase N/A
First received June 17, 2015
Last updated October 25, 2017
Start date August 2010
Est. completion date August 2015

Study information

Verified date October 2017
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 122
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Functional Magnetic Resonance Imaging
Measure brain activity.
Radiation:
Dual Energy X-ray absorptiometry
Body composition measurements.
Other:
Questionnaires
Questionnaires related to: health, weight, sleep, mood, dietary habits, attitudes towards eating, how you describe yourself.
Mood and Appetite Ratings
Answer questions about how you are feeling at the moment.
Test Meals
Breakfast, a snack, and lunch provided during study visit.
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.

Locations

Country Name City State
United States University of Washington Seattle Washington

Sponsors (3)

Lead Sponsor Collaborator
University of Washington Columbia University, Fred Hutchinson Cancer Research Center

Country where clinical trial is conducted

United States, 

Outcome

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