Summary

Eligibility
for people ages 18-45 (full criteria)
Location
at San Diego, California
Dates
study started
completion around
Principal Investigator
by Guido Frank, MD
Headshot of Guido Frank
Guido Frank

Description

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.

Official Title

Ketogenic Diet in Weight Recovered Anorexia Nervosa to Target Metabolism and Normalize Persistent Eating Disorder Psychopathology

Details

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.

Keywords

Anorexia Nervosa in Remission, Anorexia, Anorexia Nervosa, Therapeutic Ketogenic Diet

Eligibility

You can join if…

Open to people ages 18-45

  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

You CAN'T join if...

  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

Location

  • University of California San Diego accepting new patients
    San Diego California 92121 United States

Lead Scientist at UCSD

  • Guido Frank, MD
    Professor In Residence, Psychiatry, Vc-health Sciences-schools. Authored (or co-authored) 114 research publications. Research interests: Eating Disorders · Anorexia Nervosa · Bulimia Nervosa · Binge Eating Disorder · ARFID · Brain Imaging · Neuroscience · Treatment · Psychopharmacology · Psychotherapy

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT06000774
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated