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Therapeutic Ketogenic Diet in Anorexia Nervosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT06000774
Recruitment Status : Recruiting
First Posted : August 21, 2023
Last Update Posted : October 12, 2023
Information provided by (Responsible Party):
Guido Frank, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa in Remission Other: Therapeutic Ketogenic Diet Not Applicable

Detailed Description:

For this 14-week study, the investigator will recruit twenty individuals with anorexia nervosa who have been weight normalized but continue to have high impairment from the illness with a high (2 standard deviations above average) drive for thinness and body dissatisfaction and a high drive for food restriction and thus are at high risk for full relapse. Study participants will be carefully assessed and oriented to the ketogenic diet according to the procedures in our small previous trial (Calabrese, et al., 2022). The study will be conducted in a university medical environment, showing feasibility and safety in a typical medical setting. A commercial supplier will provide the ketogenic diet. After ketosis induction over two weeks, study participants will be assessed weekly for ketosis and mood, anxiety, and eating disorder symptoms.

Primary Objective 1 is to test the effects of ketogenic diet in individuals with anorexia nervosa who are weight recovered but continue to suffer severely from drive for thinness and are at very high relapse risk. Participants will be evaluated for tolerability of the study and weight trajectory. Primary Objective 2 is to assess improvement in AN symptoms and behaviors in relation to the ketogenic diet over a 12-week course. Participants will be assessed for specific symptoms such as drive for thinness and body dissatisfaction, fear of eating and weight gain. Primary Objective 3 is to assess the underlying genetic basis for the treatment effect of the ketogenic diet.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Subjects will complete a 14-week therapeutic ketogenic diet (TKD)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ketogenic Diet in Weight Recovered Anorexia Nervosa to Target Metabolism and Normalize Persistent Eating Disorder Psychopathology
Actual Study Start Date : October 3, 2023
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : March 31, 2025

Arm Intervention/treatment
Experimental: Therapeutic Ketogenic Diet
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.
Other: Therapeutic Ketogenic Diet
therapeutic ketogenic diet

Primary Outcome Measures :
  1. To assess the safety and tolerability in individuals with anorexia nervosa who are weight recovered 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.

  2. To assess the safety and tolerability in individuals with anorexia nervosa who are weight recovered 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.

  3. 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.

  4. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT06000774

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Contact: Megan Shott, BS 848-246-5272

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United States, California
University of California San Diego Recruiting
San Diego, California, United States, 92121
Contact: Megan E Shott, BS    858-246-5272   
Contact: Guido Frank, MD   
Principal Investigator: Guido Frank, MD         
Sponsors and Collaborators
University of California, San Diego
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Principal Investigator: Guido Frank, MD University of California, San Diego
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Responsible Party: Guido Frank, Professor, University of California, San Diego Identifier: NCT06000774    
Other Study ID Numbers: 807674
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: October 12, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anorexia Nervosa
Signs and Symptoms, Digestive
Feeding and Eating Disorders
Mental Disorders