Therapeutic Ketogenic Diet in Partial Hospital Program (PHP) Anorexia Nervosa
Key facts
- Who runs it
- University of California, San Diego
- Where
- San Diego, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Starts
- 1 Jan 2027
- Expected to end
- 31 Aug 2028
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Therapeutic Ketogenic Diet
- Record updated
- 3 August 2026
- Why it stopped
- Unable to start recruitment due to logistical issues working with recruitment program.
Who can take part
- Age
- 16 years to 45 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Electrolyte, blood count, kidney function or liver function abnormalities
- Pregnancy or lactation
- Psychosis
- Inability or unwillingness to adhere to the TKD diet for the duration of the study
- Blind or illiterate individuals
Where in United States
- University of California San DiegoSan Diego, United States
About the trial
What the trial wants to find out
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 of care treatment at the UCSD Eating Disorder Center partial hospital program (PHP) or intensive outpatient (IOP). Forty individuals will be recruited to the TKD and 20 will be treated with treatment as usual with respect to food intake. The age range will be between 16 and 45 years. All study participants will be carefully assessed and will complete rater and self-assessments at the being at the end of the study period. While in the treatment program, the TKD group will receive catered ketogenic meals via a meal service. After discharging from program, participants will have the option to continue with the meal service or cook for themselves. After establishing ketosis, study participants will continue TKD for 12 weeks. All study participants will be followed over three, six, and twelve months after enrolling in the study, whether initiating TKD or being in the treatment as usual arm. This follow-up procedure will help determine whether symptom improvement is stable or worsens in individuals who choose to continue or discontinue the TKD intervention and in relation to the control group. After ketosis induction over two weeks, study participants will be assessed weekly for ketosis and mood, anxiety, and eating disorder symptoms over twelve weeks.
The 2 groups in the trial
- Therapeutic Ketogenic Diet (TKD) Study ArmTreatment being tested
Participants in the TKD Study Arm will complete 14 weeks of therapeutic ketogenic diet (TKD), weekly weight and ketone measurements, weekly behavioral assessments, and meetings with the study doctor and dietician every week, and peer counseling sessions.
Treatment: Therapeutic Ketogenic Diet
- Treatment as Usual (TAU) Study ArmNo study treatment, for comparison
Participants who consent to be in the Treatment as Usual Study Arm will complete weekly weight and ketone measurements and questionnaires for 14 weeks.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Therapeutic Ketogenic Diet to Treat Anorexia Nervosa-Specific Cognitions and Behaviors - Currently Ill Individuals in PHP Level of Care and Comparison With Standard of Care
- Record updated
- 3 August 2026