NCT06000774 · University of California, San Diego
Therapeutic Ketogenic Diet in Anorexia Nervosa
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Therapeutic Ketogenic Diet
therapeutic ketogenic diet
Primary outcome measures
To assess the safety and tolerability in individuals with anorexia nervosa who are weight recovered, individuals with anorexia nervosa who are currently underweight, and individuals with bulimia nervosa using weekly body weight measurements.
Time frame: Weekly for the duration of the study intervention (14 weeks)
Weekly weights will be obtained to assess whether subjects remain within a normal weight range.
To assess the safety and tolerability in individuals with anorexia nervosa (AN) who are weight recovered, AN individuals who are currently underweight, and Bulimia Nervosa individuals using the Committee of Clinical Investigations UKU-Side Effect Scale
Time frame: At weeks 4, 8, 12, 14
The UKU assesses psychiatric, neurologic, autonomic, and other side effects.
Measurement of drive for weight loss, fear of weight gain and body image distortion using the Eating Disorder Examination Questionnaire (EDEQ) Global Score, EDEQ Eating Restraint Score, and EDEQ Weight Concern
Time frame: At baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 3 month follow-up
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, Eating Restraint, and Weight Concern scales have a range of 0 to 6 where higher scores mean worse outcome.
Measurement of the relationship between genotype and improvement of eating disorder symptoms
Time frame: At baseline
In order to identify potential genetic signatures that may predict response to treatment, Whole Exome Sequencing will be conducted on participants.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- 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
- 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
Where
- San Diego, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 5, 2025 · Source of record for eligibility and locations