Ketogenic Diet and Brain Response in Anorexia Nervosa
Recruiting now · Not applicable
Conditions studied: Anorexia Nervosa
In brief
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.
Key facts
- Study ID
- NCT06540703
- Run by
- University of California, San Diego
- People needed
- 90
- Starts
- 2024-10-02
- Expected to finish
- 2030-01-01
- Last updated by the study team
- 2026-04-23
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of California San Diego — San Diego, California, United States (enrolling)
Full record on ClinicalTrials.gov
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