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Clinical Trials/NCT05626907
NCT05626907
Completed
Not Applicable

Assessing the Effect of Diet on Hypothalamic Gliosis in Humans

University of Washington1 site in 1 country36 target enrollmentJanuary 13, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gliosis
Sponsor
University of Washington
Enrollment
36
Locations
1
Primary Endpoint
Hypothalamic Gliosis
Status
Completed
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 13, 2023
End Date
June 30, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ellen Schur, MD, MS

Professor, School of Medicine

University of Washington

Eligibility Criteria

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

Outcomes

Primary Outcomes

Hypothalamic Gliosis

Time Frame: 7 days of diet intervention

T2 relaxation time as measured by brain MRI

Study Sites (1)

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