Does What You Eat Affect Your Brain

NCT05626907 | Completed

• 2 other identifiers: STUDY000153281R01DK133356-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gliosis; Obesity; Eating

Outcome Measures

Primary Outcomes (1)

• Hypothalamic Gliosis

  T2 relaxation time as measured by brain MRI

  7 days of diet intervention

Study Arms (3)

Assigned Diet #1

EXPERIMENTAL

Other: Diet modification #1

Assigned Diet #2

EXPERIMENTAL

Other: Diet modification #2

Assigned Diet #3

OTHER

Other: Diet modification #3

Interventions

Diet modification #1 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 #1

Diet modification #2 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 #2

Diet modification #3 OTHER

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

Assigned Diet #3

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Gliosis; Obesity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Ellen A Schur, MD, MS

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: November 25, 2022
• Study Start: January 13, 2023
• Primary Completion: January 28, 2025
• Study Completion: June 30, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)