Does What You Eat Affect Your Brain (WYE)

Assessing the Effect of Diet on Hypothalamic Gliosis in Humans

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Eating; Gliosis
• Intervention / Treatment: Other: Diet modification #1; Other: Diet modification #2; Other: Diet modification #3

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary Webb; Phone Number: 206-616-6360; Email: wyestudy@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • University of Washington
      • Contact: Mary Webb; Email: wyestudy@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Assigned Diet #1	Other: 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.
Experimental: Assigned Diet #2	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.
Other: Assigned Diet #3	Other: Diet modification #3; Participants will be provided all meals for a 14-day period to be approximately 100% of estimated daily caloric needs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypothalamic Gliosis	T2 relaxation time as measured by brain MRI	7 days of diet intervention

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Ellen A Schur, MD, MS, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2023
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: September 23, 2022
• First Submitted That Met QC Criteria: November 22, 2022
• First Posted (Actual): November 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Gliosis
• Other Study ID Numbers: STUDY00015328; 1R01DK133356-01 (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