Brain Regulation of Appetite in Twins

Obesity Clinical Trial

— BRAT  

Official title:

Brain Regulation of Appetite in Twins

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02483663
• Other study ID #: 38970
• 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
• 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

Related Conditions & MeSH terms

• Appetite
• Obesity

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

External Links

•   UW Twin Registry