Ketogenic Diet and Brain Response in Anorexia Nervosa

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of California, San Diego

About this trial

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.

Eligibility criteria

Qualifiers

Age 18-45 years old

Male and Female sexes

All ethnic backgrounds

History of restricting-type anorexia nervosa (AN) according to DSM-5 criteria

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Therapeutic Ketogenic Diet (TKD)

Treatment groups

90 Participants
are divided into 1 treatment group