RECRUITING

Therapeutic Ketogenic Diet in Anorexia Nervosa

Conditions

Anorexia Nervosa in Remission Bulimia Nervosa Anorexia Nervosa

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Ketogenic Diet in Eating Disorders to Target Metabolism and Normalize Persistent Eating Disorder Psychopathology

Quick Facts

Study Start:2023-10-03

Study Completion:2027-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06000774

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Megan Shott, BS

CONTACT

848-246-5272

mshott@health.ucsd.edu

Principal Investigator

Guido Frank, MD

PRINCIPAL_INVESTIGATOR

University of California, San Diego

Study Locations (Sites)

University of California San Diego

San Diego, California, 92121

United States

Collaborators and Investigators

Sponsor: University of California, San Diego

Guido Frank, MD, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-03

Study Completion Date2027-06-30

Study Record Updates

Study Start Date2023-10-03

Study Completion Date2027-06-30

Terms related to this study

Additional Relevant MeSH Terms

Anorexia Nervosa in Remission
Bulimia Nervosa
Anorexia Nervosa