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.
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
Pregnancy or lactation
Electrolyte, blood count, kidney function or liver function abnormalities
Psychosis
Neurocognitive disorders including dementias or traumatic brain injury that is symptomatic
Parallel
Therapeutic Ketogenic Diet
Other intervention2 week induction to establish ketosis followed by 12 weeks therapeutic ketogenic diet
To assess the safety and tolerability in individuals with anorexia nervosa who are in a high level of eating disorder treatment using weekly body weight measurements.
Weekly weights will be obtained to assess whether subjects remain within the clinical goal weight range.
To assess the safety and tolerability in individuals with anorexia nervosa who are in high level of eating disorder treatment using the Committee of Clinical Investigations UKU-Side Effect Scale (UKU Side Effect Rating Scale)
The UKU Side Effect Rating Scale assesses psychic, neurologic, autonomic, and other side effects on a scale of 0 to 3 where 0 = not or doubtfully present, 1 = present to a mild degree, 2 = present to a moderate degree, 3 = present to a severe degree. The global score ranges from 0 to 48 where a higher score indicates more side effects of the study intervention.
Measurement of drive for weight loss, fear of weight gain and body image distortion using the Eating Disorder Examination Questionnaire (EDEQ) Global Score
The Eating Disorders Examination Questionnaire a self report assessment that measures core eating disorder symptoms. Subjects will complete this measure at the beginning and end of the study and weekly throughout the 14-week intervention and the investigator will measure the change in scores. The EDE Global scale has a range of 0 to 6 where higher scores mean worse outcome.
Measurement of drive for weight loss, fear of weight gain and body image distortion using the Eating Disorder Examination Questionnaire (EDEQ) Eating Restraint Score
The Eating Disorders Examination Questionnaire a self report assessment that measures core eating disorder symptoms. Subjects will complete this measure at the beginning and end of the study and weekly throughout the 14-week intervention and the investigator will measure the change in scores. The EDE Restraint scale has a range of 0 to 6 where higher scores mean worse outcome.
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