Ketogenic Diet in Weight Recovered Anorexia Nervosa to Normalize Brain Metabolism and Persistent Eating Disorder Psychopathology

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a longitudinal study with an open design in weight recovered anorexia nervosa (wrAN) individuals. Healthy controls (HC) will also be assessed. Study participants will be carefully assessed and will have 18F-fluorodeoxyglucose (\[18F\]FDG) positron emission tomography (PET) scans for assessment of regional brain glucose uptake. The wrAN group will be compared to healthy controls. Participants in the wrAN group will then complete 14 weeks of therapeutic ketogenic diet (TKD). At the end of the TKD study, participants will have assessments and a second \[18F\]FDG and TMS/EEG scan. Study participants will be followed over six months after the intervention. This follow-up procedure will help determine whether symptom improvement will be stable or worsen in individuals who choose to continue or discontinue the TKD intervention. This will be a naturalistic follow-up.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

⁃ Weight Recovered Anorexia Nervosa (wrAN)

• Age 18-45 years old

• Male and Female sexes

• All ethnic backgrounds

• History of restricting-type anorexia nervosa (AN) according to DSM-5 criteria

• Weight recovered with a body mass index \> 17.5 for at least one month at the time of study

• Elevated eating disorder-relevant behaviors on the Eating Disorders Inventory-3 and the Eating Disorder Examination Questionnaire

⁃ Healthy Control Group

• Age 18-45 years old

• Male and Female sexes

• All ethnic backgrounds

• Normal lifetime BMI according to CDC

Locations
United States
California
University of California San Diego
RECRUITING
San Diego
Time Frame
Start Date: 2024-10-02
Estimated Completion Date: 2030-01
Participants
Target number of participants: 90
Treatments
Experimental: Therapeutic Ketogenic Diet
Subjects will be placed on a therapeutic ketogenic diet (TKD) for a duration of 14 weeks.
Related Therapeutic Areas
Sponsors
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov