Therapeutic ketogenic diet for anorexia nervosa and bulimia nervosa
Ketogenic Diet in Eating Disorders to Target Metabolism and Normalize Persistent Eating Disorder Psychopathology
This 14-week program will try a therapeutic ketogenic diet to see if it helps adults with anorexia nervosa (both weight-recovered and mildly underweight) and a small pilot of people with bulimia nervosa reduce restrictive or binge‑purge behaviors and improve mood and body satisfaction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT06000774 on ClinicalTrials.gov |
What this trial studies
This interventional 14-week study enrolls primarily adults with a history of anorexia nervosa (weight-recovered and a separate underweight sub-study) and a small pilot group with bulimia nervosa to test a therapeutic ketogenic diet. Diet induction to reach nutritional ketosis occurs over two weeks and participants are monitored weekly for ketosis, weight trajectory, mood, anxiety and eating‑disorder symptoms. A commercial supplier provides the ketogenic diet and the protocol is delivered in a university medical setting at UC San Diego with safety labs and medical screening to exclude unstable medical or psychiatric conditions. Concomitant antidepressant, anxiolytic, atypical antipsychotic, and mood stabilizer medications are allowed and participants receive careful orientation and tolerability checks throughout the study.
Who should consider this trial
Good fit: Adults 18–45 with a history of anorexia nervosa who are weight-recovered (BMI ≥ 17.5) or mildly underweight (BMI 16.0–17.49) — and a small pilot includes people with bulimia nervosa — who are medically stable, English-speaking, willing to follow a ketogenic diet, and able to attend in-person visits at UC San Diego.
Not a fit: People who are medically unstable, pregnant or breastfeeding, have abnormal electrolytes or significant liver/kidney/blood count abnormalities, current alcohol use disorder, psychosis, major neurocognitive impairment, or who cannot adhere to the diet or attend in-person visits are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the ketogenic diet could reduce drive to restrict or binge‑purge behaviors, improve body satisfaction and mood, and lower relapse risk for people with eating disorders.
How similar studies have performed: Evidence is limited and preliminary: a small prior pilot (Calabrese et al., 2022) demonstrated feasibility and safety but larger trials have not yet confirmed efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
Weight-Recovered AN Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Persons, aged 18 to 45 years 4. History of anorexia nervosa according to DSM-5 criteria 5. Weight recovered at the time of study inclusion (body mass index \> 17.5 kg/m2) 6. Greater or equal to 2 standard deviations scores of eating disorder-relevant behaviors on the Eating Disorder Inventory-3 and Eating Disorder Examination Questionnaire 7. The following types of psychiatric medications are allowed: antidepressant, anxiolytic, atypical antipsychotic, mood stabilizers 8. English is primary spoken language Weight-Recovered AN Exclusion Criteria: 1. Pregnancy or lactation 2. Electrolyte, blood count, kidney function or liver function abnormalities 3. Psychosis 4. Neurocognitive disorders including dementias or traumatic brain injury that is symptomatic 5. Current alcohol use disorder (AUD) or substance use disorder (SUD) according to DSM-5 criteria 6. Uncontrolled hypertension 7. Hepatic impairment (Class-Pugh b or c) 8. Diabetes mellitus 9. Family history of porphyria 10. History of recent heart attack, vascular disease, or any other current acute medical conditions as determined by the principal investigator 11. Inability or unwillingness to adhere to the TKD diet for the duration of the study 12. Blind or illiterate individuals Underweight AN Sub-Study Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Persons, aged 18 to 45 years 4. Anorexia nervosa according to DSM-5 criteria 5. Current Body Mass Index (BMI) at the time of study inclusion of 16.0 to 17.49 6. An elevated EDE-Q global score of 2.09 or greater 7. The following types of psychiatric medications are allowed: antidepressant, anxiolytic, atypical antipsychotic, mood stabilizers 8. English is primary spoken language Underweight AN Sub-Study Exclusion Criteria: 1. Pregnancy or lactation 2. Electrolyte, blood count, kidney function or liver function abnormalities 3. Psychosis 4. Neurocognitive disorders including dementias or traumatic brain injury that is symptomatic 5. Current alcohol use disorder (AUD) or substance use disorder (SUD) according to DSM-5 criteria 6. Uncontrolled hypertension 7. Hepatic impairment (Class-Pugh b or c) 8. Diabetes mellitus 9. Family history of porphyria 10. History of recent heart attack, vascular disease, or any other current acute medical conditions as determined by the principal investigator 11. Inability or unwillingness to adhere to the TKD diet for the duration of the study 12. Blind or illiterate individuals Bulimia Nervosa Pilot Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Persons, aged 18 to 45 years 4. History of bulimia nervosa according to DSM-5 criteria 5. An elevated EDE-Q global score of 2.09 or greater 6. The following types of psychiatric medications are allowed: antidepressant, anxiolytic, atypical antipsychotic, mood stabilizers 7. English is primary spoken language Bulimia Nervosa Pilot Exclusion Criteria: 1. Pregnancy or lactation 2. Electrolyte, blood count, kidney function or liver function abnormalities 3. Psychosis 4. Neurocognitive disorders including dementias or traumatic brain injury that is symptomatic 5. Current alcohol use disorder (AUD) or substance use disorder (SUD) according to DSM-5 criteria 6. Uncontrolled hypertension 7. Hepatic impairment (Class-Pugh b or c) 8. Diabetes mellitus 9. Family history of porphyria 10. History of recent heart attack, vascular disease, or any other current acute medical conditions as determined by the principal investigator 11. Inability or unwillingness to adhere to the TKD diet for the duration of the study 12. Blind or illiterate individuals
Where this trial is running
San Diego, California
- University of California San Diego — San Diego, California, United States (Recruiting)
Study contacts
- Principal investigator: Guido Frank, MD — University of California, San Diego
- Study coordinator: Megan Shott, BS
- Email: mshott@health.ucsd.edu
- Phone: 848-246-5272
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.