Status:
NOT_YET_RECRUITING
Therapeutic Ketogenic Diet in Partial Hospital Program (PHP) Anorexia Nervosa
Lead Sponsor:
University of California, San Diego
Conditions:
Anorexia Nervosa
Eligibility:
All Genders
16-45 years
Phase:
NA
Brief Summary
This will be a 14-week longitudinal study with an open design. A total of 120 individuals will be recruited for an end goal of 60 individuals with anorexia nervosa (AN) who are currently in high level...
Detailed Description
For this 14-week study, 60 individuals with anorexia nervosa (AN) who are currently in high level of care treatment at the UC San Diego Health Eating Disorders Center for Treatment and Research (UC Sa...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form/parental permission form
- Provision of signed and dated assent form if the subject is a minor
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Persons, aged 16 to 45 years
- Current anorexia nervosa diagnosis according to DSM-5 criteria
- An elevated EDE-Q global score of 2.09 or greater
- The following types of psychiatric medications are allowed: antidepressant, anxiolytic, atypical antipsychotic, mood stabilizers
- English is primary spoken language
Exclusion
- Pregnancy or lactation
- Electrolyte, blood count, kidney function or liver function abnormalities
- Psychosis
- Neurocognitive disorders including dementias or traumatic brain injury that is symptomatic
- Current alcohol use disorder (AUD) or substance use disorder (SUD) according to DSM-5 criteria
- Uncontrolled hypertension
- Hepatic impairment (Class-Pugh b or c)
- Diabetes mellitus
- Family history of porphyria
- History of recent heart attack, vascular disease, or any other current acute medical conditions as determined by the principal investigator
- Inability or unwillingness to adhere to the TKD diet for the duration of the study
- Blind or illiterate individuals
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06605027
Start Date
January 1 2026
End Date
August 31 2028
Last Update
September 2 2025
Active Locations (1)
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1
University of California San Diego
San Diego, California, United States, 92121