Therapeutic ketogenic diet for anorexia nervosa and bulimia nervosa
Official title: Ketogenic Diet in Eating Disorders to Target Metabolism and Normalize Persistent Eating Disorder Psychopathology
Run by University of California, San Diego · NCT06000774 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (San Diego, California) |
| Status | Recruiting |
| Started | October 3, 2023 |
| Main results expected | June 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | September 5, 2025 |
| Trial ID | NCT06000774 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Eating Disorder Dynamic Intervention
A digital program is tested to help adults with eating disorders by sending real-time, personalized coping tips based on smartphone surveys and sensor data.
-
Cognitive evaluation for people with eating disorders
This project tests whether thinking skills (like cognitive flexibility and inhibitory control) and automatic food-related attitudes differ among people aged 14–65 with ARFID, anorexia, or bulimia.
-
An AI chatbot to help teens and young adults with eating disorders manage anxiety about weight gain
This project will test an AI-powered chatbot that delivers exposure-based exercises to help adolescents and young adults in a partial hospitalization program reduce anxiety about weight gain.
-
Digital twins to classify mental health patterns in adults with diabetes
This project will try to create 'digital twin' profiles that combine glucose, mood, and behavior data to track mental health patterns in adults with diabetes.
-
Gastrointestinal symptoms during weight restoration in anorexia nervosa and bulimia nervosa with different diets
This project will test whether different nutritional strategies (flexitarian, vegetarian, or vegan) change gastrointestinal symptoms during multi-week inpatient weight rehabilitation for people with anorexia nervosa or bulimia nervosa.
-
Using fMRI to study brain activity in patients with eating disorders
This study is testing how brain activity changes in people with anorexia or bulimia over a year to see if these changes relate to their symptoms getting better.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.