Status:
RECRUITING
Ketogenic Diet and Brain Response in Anorexia Nervosa
Lead Sponsor:
University of California, San Diego
Conditions:
Anorexia Nervosa
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
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...
Detailed Description
Anorexia nervosa (AN) is a severe psychiatric disorder. However, neurobiological models and interventions to explain and treat the core characteristics of food restriction, feeling fat, and body size ...
Eligibility Criteria
Inclusion
- Weight Recovered Anorexia Nervosa (wrAN)
- 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
- Healthy Control Group
- Age 18-45 years old
- Male and Female sexes
- All ethnic backgrounds
- Normal lifetime BMI according to CDC
Exclusion
- Weight Recovered Anorexia Nervosa (AN)
- 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
- Healthy Control Group
- 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.
- No subject in either group will have or be
- 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
Key Trial Info
Start Date :
October 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2030
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06540703
Start Date
October 2 2024
End Date
January 1 2030
Last Update
March 26 2025
Active Locations (1)
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1
University of California San Diego
San Diego, California, United States, 92121