Therapeutic Ketogenic Diet in Partial Hospital Program (PHP) Anorexia Nervosa

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-45
SponsorUniversity of California, San Diego

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Pregnancy or lactation

Electrolyte, blood count, kidney function or liver function abnormalities

Psychosis

Neurocognitive disorders including dementias or traumatic brain injury that is symptomatic

Trial design

Treatments tested in this trial

  • Therapeutic Ketogenic Diet

Treatment groups

120 Participants
are divided into 2 treatment groups