NCT06000774 Therapeutic Ketogenic Diet in Anorexia Nervosa
| NCT ID | NCT06000774 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Diego |
| Condition | Anorexia Nervosa in Remission |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-10-03 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2023-10-03 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. 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.
Eligibility 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
Contact & Investigator
Guido Frank, MD
PRINCIPAL INVESTIGATOR
University of California, San Diego
Frequently Asked Questions
Who can join the NCT06000774 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Anorexia Nervosa in Remission. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06000774 currently recruiting?
Yes, NCT06000774 is actively recruiting participants. Contact the research team at mshott@health.ucsd.edu for enrollment information.
Where is the NCT06000774 trial being conducted?
This trial is being conducted at San Diego, United States.
Who is sponsoring the NCT06000774 clinical trial?
NCT06000774 is sponsored by University of California, San Diego. The principal investigator is Guido Frank, MD at University of California, San Diego. The trial plans to enroll 20 participants.