- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07430852
Inherited and Environmental Risks Acting on Body Weight (INTERACT)
February 18, 2026 updated by: Ellen Schur, MD, MS, University of Washington
Genetic and Environmental Contributions to Obesity Pathogenesis
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.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
110
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: INTERACT Study
- Phone Number: 206-616-6360
- Email: interactstudy@uw.edu
Study Locations
-
-
Washington
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Seattle, Washington, United States, 98109
- University of Washington
-
Contact:
- INTERACT Study
- Phone Number: 206-616-6360
- Email: interactstudy@uw.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Study 1, A co-twin control study of habitual diet
Monozygotic twin pairs with differential habitual diet practices will undergo measurements including body composition, and MRI measures of hepatic adiposity and neuroinflammation.
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|
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Experimental: Study 2, A twin study of controlled diet
Monozygotic twin pairs will be provided an assigned diet for 14-days.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Study 1: Hypothalamic Gliosis
Time Frame: at enrollment
|
T2 relaxation time as measured by brain MRI
|
at enrollment
|
|
Study 2: Hypothalamic Gliosis
Time Frame: 7 days of diet intervention
|
T2 relaxation time as measured by brain MRI
|
7 days of diet intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ellen Schur, MD, MS, University of Washington
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
November 1, 2029
Study Completion (Estimated)
April 30, 2030
Study Registration Dates
First Submitted
February 18, 2026
First Submitted That Met QC Criteria
February 18, 2026
First Posted (Actual)
February 24, 2026
Study Record Updates
Last Update Posted (Actual)
February 24, 2026
Last Update Submitted That Met QC Criteria
February 18, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00022649
- R01DK144233 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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