Ketogenic Diet and Brain Response in Anorexia Nervosa

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT06540703
Status
Recruiting
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Conditions

  • Anorexia Nervosa

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Therapeutic Ketogenic Diet (TKD) — DIETARY_SUPPLEMENT
    2 week induction to establish ketosis followed by 12 weeks therapeutic ketogenic diet

Study Details

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 Dates

Start date
Oct 2, 2024
Status verified
Apr 2026
Primary completion
May 31, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
90 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Therapeutic Ketogenic Diet
    Subjects will be placed on a therapeutic ketogenic diet (TKD) for a duration of 14 weeks.

Primary Outcome Measure

[18F]fluorodeoxyglucose (FDG) uptake [ Time Frame: Difference in pre/post Therapeutic Ketogenic Diet PET/CT scans ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San DiegoSan DiegoCalifornia92121
Megan E Shott, BS
[email protected]
858-246-5272
Guido Frank, MD
[email protected]
Guido Frank, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of California San Diego· San Diego, CA

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