Recruiting

Therapeutic Ketogenic Diet

Sponsor:

UCLA

Code:

NCT06000774

Conditions

Anorexia Nervosa in Remission

Bulimia Nervosa

Anorexia Nervosa

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Therapeutic Ketogenic Diet

Study Details

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

Study ID

NCT06000774

Start date

Oct 3, 2023

Status verified date

Aug, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Therapeutic Ketogenic Diet

therapeutic ketogenic diet

Primary outcome measure

  • 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) ]
  • 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 ]
  • 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 ]
  • Measurement of the relationship between genotype and improvement of eating disorder symptoms [ Time Frame: At baseline ]

Central Contacts and Locations

Central contacts

Locations

University of California San Diego

Recruiting

San Diego, California, United States, 92121

Contacts

Principal Investigator:

Guido Frank, MD

More Information

Sponsor

University of California, San Diego

Last update posted

Sep 5, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2025-09-05.