Taking people in United StatesNo phase

Therapeutic Ketogenic Diet in Anorexia Nervosa

Key facts

Who runs it: University of California, San Diego
Where: San Diego, United StatesSee the site
Trial code: NCT06000774
Status: Recruiting
People taking part: 20 people, planned
Started: 3 Oct 2023
Expected to end: 30 Jun 2027
Type of study: Interventional
Treatments tested: Therapeutic Ketogenic Diet
Record updated: 5 September 2025

Who can take part

Age: 18 years to 45 years
Sex: Women and men
Healthy volunteers: Cannot take part

The registry criteria, word for word

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Other criteria

Weight-Recovered AN 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
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 Criteria:
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 Exclusion Criteria:
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; Bulimia Nervosa Pilot 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
History of bulimia nervosa 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; Bulimia Nervosa Pilot Exclusion Criteria:
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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 45 years old?

Where in United States

University of California San DiegoSan Diego, United StatesContact: Megan E Shott, BSTaking people

About the trial

What the trial wants to find out

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 who have been weight normalized (body mass index of 17.5 or greater) but continue to struggle with eating disorder behaviors including a high drive for thinness and body dissatisfaction.

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The Underweight Anorexia Nervosa (AN) Sub-Study will investigate the effects of TKD on eating behavior including drive to restrict, body dissatisfaction, mood and anxiety in individuals with anorexia nervosa who are currently underweight (body mass index between 16.0 and 17.49) and continue to struggle with eating disorder behaviors including a high drive for thinness and body dissatisfaction.

The Bulimia Nervosa Pilot will will investigate the effects of TKD on eating behavior including drive to binge and purge, body dissatisfaction, mood and anxiety in individuals with bulimia nervosa.

The group in the trial

Therapeutic Ketogenic DietTreatment being tested
A 2-week therapeutic ketogenic diet (TKD) induction will be implemented to establish nutritional ketosis (the goal are BHB blood levels of 0.5-3.0 millimoles per liter \[mmol/L\]). After establishing the ketotic state, study participants will continue TKD for 12 weeks.