Ketogenic Diet and Brain Response in Anorexia Nervosa

NCT06540703 | Recruiting DMC

• 1 other identifier: 810326
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (1)

• [18F]fluorodeoxyglucose (FDG) uptake

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

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

Study Arms (1)

Therapeutic Ketogenic Diet

EXPERIMENTAL

Subjects will be placed on a therapeutic ketogenic diet (TKD) for a duration of 14 weeks.

Dietary Supplement: Therapeutic Ketogenic Diet (TKD)

Interventions

Therapeutic Ketogenic Diet (TKD) DIETARY_SUPPLEMENT

2 week induction to establish ketosis followed by 12 weeks therapeutic ketogenic diet

Therapeutic Ketogenic Diet

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

San Diego, California, 92121, United States

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: therapeutic ketogenic diet for 14 weeks

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 6, 2024
• Study Start: October 2, 2024
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)