NCT06540703 · University of California, San Diego
Ketogenic Diet and Brain Response in Anorexia Nervosa
What this study is about
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.
View original scientific 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.
Interventions
DIETARY_SUPPLEMENT
Therapeutic Ketogenic Diet (TKD)
2 week induction to establish ketosis followed by 12 weeks therapeutic ketogenic diet
Primary outcome measures
[18F]fluorodeoxyglucose (FDG) uptake
Time frame: Difference in pre/post Therapeutic Ketogenic Diet PET/CT scans
To test whether TKD will be associated with reduced brain \[18F\]fluorodeoxyglucose (FDG) uptake
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
- 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
- San Diego, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 23, 2026 · Source of record for eligibility and locations