Inherited and Environmental Risks Acting on Body Weight
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diet modification.
- Who it may be relevant to
- Registry conditions: Genetics, Obesity. Basic parameters: 20 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Genetic and Environmental Contributions to Obesity Pathogenesis
Overview
The goal of this research is to investigate genetic and environmental factors that contribute to obesity through brain inflammation. The main questions are 1) if identical twins, who differ in food consumption habits, have differences in adiposity markers and brain inflammation and 2) if signs of brain inflammation in response to a specific diet is modified by genetics.
Detailed description
In study 1, participant twin pairs that differ in habitual diet intake, will complete an in-person study visit that includes an MRI of the brain and abdomen, body composition measurement, a blood draw and questionnaires. In study 2, a different set of participant twin pairs will complete 3 in-person study visits over 2 weeks, during which all meals will be provided by the study. Visits will include brain MRI, body composition measurements, blood draws and questionnaires.
Interventions
- Behavioral Diet modification
Participants will be provided all meals for a 14-day period. For 7 of the days, meals will be 150% of estimated daily caloric needs and for the other 7 days, meals will be low in calories, consistent with recommendations for weight loss.
Primary outcome measures
- Study 1: Hypothalamic Gliosis [Time frame: at enrollment]
- Study 2: Hypothalamic Gliosis [Time frame: 7 days of diet intervention]
Eligibility criteria
Inclusion criteria
- Age 20-45 years
- Differs in habitual diet from co-twin (study 1).
- Willing to undergo 7-day overfeeding and hypocaloric feeding periods (study 2)
- Member of the Washington State Twin Registry
Exclusion criteria
- History of bariatric surgery or active participation in weight-loss program
- Major medical or neurological disorder (e.g., diabetes, multiple sclerosis)
- Known gallbladder disease, anemia, impaired thyroid, kidney or liver function or hypertriglyceridemia (>350 mg/dl) (study 2)
- Current use of weight-loss medications or other medications known to alter appetite (e.g., atypical anti-psychotics)
- High levels of vigorous physical activity (>300 min./week)
- Pregnancy, menopause, or breastfeeding
- Individuals with severe food allergies and dietary restrictions (e.g., vegan/vegetarian, gluten-free, others) (study 2)
- Co-twin unwilling or unable to participate
- MRI contraindication (e.g., implanted metal, claustrophobia)
- Lifetime eating disorder
- Current smoking or heavy alcohol use (≥ 2 drinks per day for females and ≥ 3 drinks per day for males)
- BMI > 45 kg/m2 (study 1)
- BMI > 35 kg/m2 (study 2)
- Weight > 350 pounds or determined to be safe by MRI tech (MRI limit)
- Inability to participate in a controlled diet program (study 2) or undergo other study procedures
- Non-English speaking-or-reading individuals
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Washington — Seattle
Identifiers
NCT: NCT07430852 · STUDY00022649 · R01DK144233