Ketogenic Diet and Brain Response in Anorexia Nervosa

ConditionAnorexia 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

This trial accepts healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Therapeutic Ketogenic Diet (TKD)
Dietary supplement
2 week induction to establish ketosis followed by 12 weeks therapeutic ketogenic diet

Treatment groups

90 Participants

are divided into 1 treatment group

Group A: Therapeutic Ketogenic DietExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

[18F]fluorodeoxyglucose (FDG) uptake

To test whether TKD will be associated with reduced brain \[18F\]fluorodeoxyglucose (FDG) uptake

Time frame

Difference in pre/post Therapeutic Ketogenic Diet PET/CT scans

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Diego

Lead sponsor

Source ClinicalTrials.gov

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