Therapeutic Ketogenic Diet in Anorexia Nervosa

NCT06000774 | Recruiting

• 1 other identifier: 807674
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa in Remission; Bulimia Nervosa; Anorexia Nervosa

Outcome Measures

Primary Outcomes (4)

• 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.

  Weekly weights will be obtained to assess whether subjects remain within a normal weight range.

  Weekly for the duration of the study intervention (14 weeks)

• 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

  The UKU assesses psychiatric, neurologic, autonomic, and other side effects.

  At weeks 4, 8, 12, 14

• 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

  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.

  At baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 3 month follow-up

• Measurement of the relationship between genotype and improvement of eating disorder symptoms

  In order to identify potential genetic signatures that may predict response to treatment, Whole Exome Sequencing will be conducted on participants.

  At baseline

Study Arms (1)

Therapeutic Ketogenic Diet

EXPERIMENTAL

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

Interventions

Therapeutic Ketogenic Diet OTHER

therapeutic ketogenic diet

Therapeutic Ketogenic Diet

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• Pregnancy or lactation
• Electrolyte, blood count, kidney function or liver function abnormalities
• Psychosis
• 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
• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

San Diego, California, 92121, United States

RECRUITING

Related Publications (5)

• Scolnick B, Zupec-Kania B, Calabrese L, Aoki C, Hildebrandt T. Remission from Chronic Anorexia Nervosa With Ketogenic Diet and Ketamine: Case Report. Front Psychiatry. 2020 Jul 30;11:763. doi: 10.3389/fpsyt.2020.00763. eCollection 2020.

  PMID: 32848935 BACKGROUND

• Frank GKW, Shott ME, DeGuzman MC. The Neurobiology of Eating Disorders. Child Adolesc Psychiatr Clin N Am. 2019 Oct;28(4):629-640. doi: 10.1016/j.chc.2019.05.007. Epub 2019 Jul 4.

  PMID: 31443880 BACKGROUND

• Frank GKW, Shott ME, Stoddard J, Swindle S, Pryor TL. Association of Brain Reward Response With Body Mass Index and Ventral Striatal-Hypothalamic Circuitry Among Young Women With Eating Disorders. JAMA Psychiatry. 2021 Oct 1;78(10):1123-1133. doi: 10.1001/jamapsychiatry.2021.1580.

  PMID: 34190963 BACKGROUND

• Dignon A, Beardsmore A, Spain S, Kuan A. 'Why I won't eat': patient testimony from 15 anorexics concerning the causes of their disorder. J Health Psychol. 2006 Nov;11(6):942-56. doi: 10.1177/1359105306069097.

  PMID: 17035265 BACKGROUND

• Calabrese L, Scolnick B, Zupec-Kania B, Beckwith C, Costello K, Frank GKW. Ketogenic diet and ketamine infusion treatment to target chronic persistent eating disorder psychopathology in anorexia nervosa: a pilot study. Eat Weight Disord. 2022 Dec;27(8):3751-3757. doi: 10.1007/s40519-022-01455-x. Epub 2022 Aug 23.

  PMID: 35997954 BACKGROUND

MeSH Terms

Conditions

Bulimia Nervosa; Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Guido Frank, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Shott, BS

CONTACT

848-246-5272; mshott@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Subjects will complete a 14-week therapeutic ketogenic diet (TKD)

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: October 3, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)