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OpenTrials
Completed

NCT Number: NCT05626907

Does What You Eat Affect Your Brain

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.

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Key information

Conditions

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

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Diet modification #3

Other

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

Primary outcomes

  1. Hypothalamic Gliosis

    Time frame: 7 days of diet intervention

    T2 relaxation time as measured by brain MRI

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

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

Registry information

Official study title

Assessing the Effect of Diet on Hypothalamic Gliosis in Humans

Acronym: WYE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 25, 2022
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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