RecruitingNot Applicable

Ketogenic Diet and Brain Response in Anorexia Nervosa

United States90 participantsStarted 2024-10-02

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * dementia * psychotic disorder * bipolar disorder * somatic symptom * conversion disorder * current alcohol or su…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

[18F]fluorodeoxyglucose (FDG) uptake

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

Trial details

NCT IDNCT06540703

SponsorUniversity of California, San Diego

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-05

View on ClinicalTrials.gov More Anorexia Nervosa trials