Status:
RECRUITING
Therapeutic Ketogenic Diet in Anorexia Nervosa
Lead Sponsor:
University of California, San Diego
Conditions:
Anorexia Nervosa in Remission
Bulimia Nervosa
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
This study will investigate the effects of therapeutic ketogenic diet (TKD) on eating behavior including drive to restrict, body dissatisfaction, mood and anxiety in individuals with anorexia nervosa ...
Detailed Description
For this 14-week study, the investigator will recruit twenty individuals with anorexia nervosa who have been weight normalized but continue to have high impairment from the illness with a high (2 stan...
Eligibility Criteria
Inclusion
- Weight-Recovered AN
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Persons, aged 18 to 45 years
- History of anorexia nervosa according to DSM-5 criteria
- Weight recovered at the time of study inclusion (body mass index \> 17.5 kg/m2)
- Greater or equal to 2 standard deviations scores of eating disorder-relevant behaviors on the Eating Disorder Inventory-3 and Eating Disorder Examination Questionnaire
- The following types of psychiatric medications are allowed: antidepressant, anxiolytic, atypical antipsychotic, mood stabilizers
- English is primary spoken language
- Weight-Recovered AN
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
- Underweight AN Sub-Study Inclusion Criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Persons, aged 18 to 45 years
- Anorexia nervosa according to DSM-5 criteria
- Current Body Mass Index (BMI) at the time of study inclusion of 16.0 to 17.49
- 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
- Underweight AN Sub-Study
Key Trial Info
Start Date :
October 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06000774
Start Date
October 3 2023
End Date
June 30 2027
Last Update
September 5 2025
Active Locations (1)
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1
University of California San Diego
San Diego, California, United States, 92121