Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2023-01-13
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Assigned Diet #1
Diet modification #1
Participants will be provided all meals for a 14-day period. For 7 of the days, meals will be 130% of estimated daily caloric needs and for the other 7 days, meals will be low in calories, consistent with recommendations for weight loss.
Assigned Diet #2
Diet modification #2
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 meals will be low in calories, consistent with recommendations for weight loss.
Assigned Diet #3
Diet modification #3
Participants will be provided all meals for a 14-day period to be approximately 100% of estimated daily caloric needs.
Interventions
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Diet modification #1
Participants will be provided all meals for a 14-day period. For 7 of the days, meals will be 130% of estimated daily caloric needs and for the other 7 days, meals will be low in calories, consistent with recommendations for weight loss.
Diet modification #2
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 meals will be low in calories, consistent with recommendations for weight loss.
Diet modification #3
Participants will be provided all meals for a 14-day period to be approximately 100% of estimated daily caloric needs.
Eligibility Criteria
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Inclusion Criteria
* Overweight: BMI 25-29.9 kg/m2
* Willing to undergo randomly assigned 14-day diet modification
Exclusion Criteria
* Major medical or neurological disorder (e.g., diabetes, multiple sclerosis)
* Anemia or impaired kidney or liver function
* Known gallbladder disease or gallstones
* Hypertriglyceridemia (\>350 mg/dl)
* Current use of orlistat or other weight-loss medications or other medications known to alter appetite (e.g., atypical anti-psychotics)
* More than moderate level of physical activity (\>1000 met-min/wk)
* Pregnancy, menopause, or breastfeeding
* 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)
* Weight \> 350 pounds (MRI limit)
* Dietary restrictions (e.g., vegan) incompatible with controlled diets
20 Years
40 Years
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Washington
OTHER
Responsible Party
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Ellen Schur, MD, MS
Professor, School of Medicine
Principal Investigators
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Ellen A Schur, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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University of Washington
Seattle, Washington, United States
Countries
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Other Identifiers
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STUDY00015328
Identifier Type: -
Identifier Source: org_study_id
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