RECRUITING

Ketogenic Diet and Brain Response in 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 is a longitudinal study with an open design in weight recovered anorexia nervosa (wrAN) individuals. Healthy controls (HC) will also be assessed. Study participants will be carefully assessed and will have 18F-fluorodeoxyglucose (\[18F\]FDG) positron emission tomography (PET) scans for assessment of regional brain glucose uptake. The wrAN group will be compared to healthy controls. Participants in the wrAN group will then complete 14 weeks of therapeutic ketogenic diet (TKD). At the end of the TKD study, participants will have assessments and a second \[18F\]FDG and TMS/EEG scan. Study participants will be followed over six months after the intervention. This follow-up procedure will help determine whether symptom improvement will be stable or worsen in individuals who choose to continue or discontinue the TKD intervention. This will be a naturalistic follow-up.

Official Title

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

Quick Facts

Study Start:2024-10-02

Study Completion:2030-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06540703

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:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Age 18-45 years old * Male and Female sexes * All ethnic backgrounds * History of restricting-type anorexia nervosa (AN) according to DSM-5 criteria * Weight recovered with a body mass index \> 17.5 for at least one month at the time of study * Elevated eating disorder-relevant behaviors on the Eating Disorders Inventory-3 and the Eating Disorder Examination Questionnaire * Age 18-45 years old * Male and Female sexes * All ethnic backgrounds * Normal lifetime BMI according to CDC	* Current pregnancy or nursing (will have to agree to contraceptive measures if sexually active) * Lifetime history of bipolar I disorder or psychosis * Current substance abuse or dependence in the past 3 months * Psychotic illness/other organic brain syndromes, dementia, somatization disorders or conversion disorders * History of significant head trauma * Indication of intellectual disability or autism spectrum disorder * No lifetime psychiatric illness and in particular no eating disorder history * Not be taking medication, and will not have a first degree relative with an eating disorder. * mental retardation or pervasive developmental disorder * organic brain syndrome * dementia * psychotic disorder * bipolar disorder * somatic symptom * conversion disorder * current alcohol or substance use disorder * indication of major medical illness including a history of seizure disorder * pregnant or nursing at the time of the study * a history of traumatic brain injury. * diabetes mellitus or other metabolic disorders that could worsen on a ketogenic diet * intracranial or any other metal object within or near the head that cannot be safely removed, excluding the mouth * implanted neurostimulators, intracardiac lines, or heart disease

Inclusion Criteria

Exclusion Criteria

* Age 18-45 years old
* Male and Female sexes
* All ethnic backgrounds
* History of restricting-type anorexia nervosa (AN) according to DSM-5 criteria
* Weight recovered with a body mass index \> 17.5 for at least one month at the time of study
* Elevated eating disorder-relevant behaviors on the Eating Disorders Inventory-3 and the Eating Disorder Examination Questionnaire
* Age 18-45 years old
* Male and Female sexes
* All ethnic backgrounds
* Normal lifetime BMI according to CDC

* Current pregnancy or nursing (will have to agree to contraceptive measures if sexually active)
* Lifetime history of bipolar I disorder or psychosis
* Current substance abuse or dependence in the past 3 months
* Psychotic illness/other organic brain syndromes, dementia, somatization disorders or conversion disorders
* History of significant head trauma
* Indication of intellectual disability or autism spectrum disorder
* No lifetime psychiatric illness and in particular no eating disorder history
* Not be taking medication, and will not have a first degree relative with an eating disorder.
* mental retardation or pervasive developmental disorder
* organic brain syndrome
* dementia
* psychotic disorder
* bipolar disorder
* somatic symptom
* conversion disorder
* current alcohol or substance use disorder
* indication of major medical illness including a history of seizure disorder
* pregnant or nursing at the time of the study
* a history of traumatic brain injury.
* diabetes mellitus or other metabolic disorders that could worsen on a ketogenic diet
* intracranial or any other metal object within or near the head that cannot be safely removed, excluding the mouth
* implanted neurostimulators, intracardiac lines, or heart disease

Contacts and Locations

Study Locations (Sites)

University of California San Diego

San Diego, California, 92121

United States

Collaborators and Investigators

Sponsor: 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 Date2024-10-02

Study Completion Date2030-01

Study Record Updates

Study Start Date2024-10-02

Study Completion Date2030-01

Terms related to this study

Additional Relevant MeSH Terms

Anorexia Nervosa