Clinical trial NCT02483663: Brain Regulation of Appetite in Twins
Official title: Brain Regulation of Appetite in Twins
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Appetite
Keywords: Twins
Obesity
Appetite
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Fred Hutchinson Cancer Center
name: Columbia University
First posted: 2015-06-29
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Monozygotic and dizygotic twins recruited from the University of Washington Twin Registry

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.


Eligibility criteria: 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

Primary outcomes:
measure: Meal-induced nutrient and hormonal changes in plasma (insulin, GLP-1, ghrelin, glucose)
timeFrame: Baseline
measure: Brain activation during fMRI in satiety-related regions
timeFrame: Baseline
measure: Body composition: fasting leptin and dual energy X-ray absorptiometry (DXA)
timeFrame: Baseline
measure: DNA evaluation of FTO genotypes
timeFrame: Baseline
measure: Objective satiety: caloric and macronutrient intake
timeFrame: Baseline
measure: Subjective satiety: visual analog scale (VAS) scores and appeal ratings
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Ellen Schur, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.