Does What You Eat Affect Your Brain

Obesity Clinical Trial

— WYE  

Official title:

Assessing the Effect of Diet on Hypothalamic Gliosis in Humans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05626907
• Other study ID #: STUDY00015328
• Secondary ID: 1R01DK133356-01
• Status: Recruiting
• Phase: N/A
• Start date: January 13, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: University of Washington
• Contact: WYE Study
• Phone: 206-616-6360
• Email: wyestudy[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: June 30, 2025
• Est. primary completion date: March 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Eating
• Gliosis
• Obesity

Intervention

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.
• 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.
• Diet modification #3
Participants will be provided all meals for a 14-day period to be approximately 100% of estimated daily caloric needs.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypothalamic Gliosis	T2 relaxation time as measured by brain MRI	7 days of diet intervention