Does What You Eat Affect Your Brain

NCT ID: NCT05626907

Last Updated: 2025-08-29

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-13

Study Completion Date

2025-06-30

Brief Summary

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The purpose of this study is to use magnetic resonance imaging (MRI) to evaluate the human hypothalamus for signs of inflammation in response to specific diets. This research may lead to a better understanding of how poor nutritional quality may lead to obesity through effects on regions of the brain known to regulate body weight.

Detailed Description

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Conditions

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Gliosis Obesity Eating

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Assigned Diet #1

Group Type EXPERIMENTAL

Diet modification #1

Intervention Type OTHER

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

Group Type EXPERIMENTAL

Diet modification #2

Intervention Type OTHER

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

Group Type OTHER

Diet modification #3

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Diet modification #3

Participants will be provided all meals for a 14-day period to be approximately 100% of estimated daily caloric needs.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 20-40 years
* Overweight: BMI 25-29.9 kg/m2
* Willing to undergo randomly assigned 14-day diet modification

Exclusion Criteria

* History of bariatric surgery or active participation in weight-loss program
* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Ellen Schur, MD, MS

Professor, School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

Other Identifiers

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1R01DK133356-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00015328

Identifier Type: -

Identifier Source: org_study_id

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