Anorexia NervosaNCT06540703
Ketogenic Diet and Brain Response in Anorexia Nervosa
A study testing Therapeutic Ketogenic Diet (TKD) in people with Anorexia Nervosa, run by University of California, San Diego at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Therapeutic Ketogenic Diet (TKD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2024to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 substance use disorder
- indication of major medical illness including a history of seizure disorder
- pregnant or nursing at the time of the study
- a history of traumatic brain injury.
- diabetes mellitus or other metabolic disorders that could worsen on a ketogenic diet
- intracranial or any other metal object within or near the head that cannot be safely removed, excluding the mouth
- implanted neurostimulators, intracardiac lines, or heart disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California San Diego
San Diego, California, 92121
Megan E Shott, BS, 858-246-5272, mshott@health.ucsd.edu
Guido Frank, MD, gfrank@health.ucsd.edu
About this study
Official title: Ketogenic Diet in Weight Recovered Anorexia Nervosa to Normalize Brain Metabolism and Persistent Eating Disorder Psychopathology
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.
Read the detailed description
Anorexia nervosa (AN) is a severe psychiatric disorder. However, neurobiological models and interventions to explain and treat the core characteristics of food restriction, feeling fat, and body size overestimation are lacking. While research has made progress in understanding brain function involved in AN pathophysiology, translating those results into biological therapies has been challenging. Studies have suggested that metabolic factors contribute to developing and maintaining AN pathophysiology. Specifically, brain glucose utilization and metabolism may be altered in AN, interfere with brain energy homeostasis, and contribute to illness development and maintenance. A small study indicated that ketosis might be therapeutic for AN core behaviors such as eating and shape concerns. In this application, the investigator will study individuals weight recovered from AN, establish biological targets as diet-related metabolic markers for AN (R61 phase), and replicate and link those targets to AN-specific behaviors (R33 phase). The weight recovered AN group will also be compared with a healthy control sample. The R61 Phase Specific Aim of the project is to establish target engagement for a therapeutic ketogenic diet (TKD) in AN after weight recovery and establish safety and tolerability. It is hypothesized that TKD will be associated with reduced brain glucose metabolism using [18F]fluorodeoxyglucose ([18F]FDG) and positron emission tomography (PET) (target engagement). Higher blood ketosis levels will be associated with a more significant reduction of the brain [18F]FDG glucose metabolism rate (dose dependency). It is hypothesized that TKD will be well tolerated, that participants will remain within the normal weight range (tolerability), and that study participants will be able to adhere to TKD as indicated by regular blood ketosis measurements (treatment fidelity). There will be an initial indication that TKD and associated biological measures correlate with behavioral measures derived from eating disorder-specific assessments.
- Conditions
- Anorexia Nervosa
- Being tested
- Therapeutic Ketogenic Diet (TKD)
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Ketogenic Diet (TKD)Dietary supplement
2 week induction to establish ketosis followed by 12 weeks therapeutic ketogenic diet
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Ketogenic Diet | Experimental | Subjects will be placed on a therapeutic ketogenic diet (TKD) for a duration of 14 weeks. Receives: Dietary Supplement: Therapeutic Ketogenic Diet (TKD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
[18F]fluorodeoxyglucose (FDG) uptake
To test whether TKD will be associated with reduced brain [18F]fluorodeoxyglucose (FDG) uptake
Measured: Difference in pre/post Therapeutic Ketogenic Diet PET/CT scans
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start2 Oct 2024
- Primary completionMay 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- therapeutic ketogenic diet for 14 weeks
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guido Frank, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540703
- Sponsor's protocol ID
- 810326
- Status last verified
- Apr 2026
- First submitted
- 2 Aug 2024
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketogenic Diet in Weight Recovered Anorexia Nervosa to Normalize Brain Metabolism and Persistent Eating Disorder Psychopathology
- ClinicalTrials.gov ID
- NCT06540703
- Acronym / sponsor ID
- 810326
- Conditions
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Anorexia nervosa (AN) is a severe psychiatric disorder. However, neurobiological models and interventions to explain and treat the core characteristics of food restriction, feeling fat, and body size overestimation are lacking. While research has made progress in understanding brain function involved in AN pathophysiology, translating those results into biological therapies has been challenging. Studies have suggested that metabolic factors contribute to developing and maintaining AN pathophysiology. Specifically, brain glucose utilization and metabolism may be altered in AN, interfere with brain energy homeostasis, and contribute to illness development and maintenance. A small study indicated that ketosis might be therapeutic for AN core behaviors such as eating and shape concerns. In this application, the investigator will study individuals weight recovered from AN, establish biological targets as diet-related metabolic markers for AN (R61 phase), and replicate and link those targets to AN-specific behaviors (R33 phase). The weight recovered AN group will also be compared with a healthy control sample. The R61 Phase Specific Aim of the project is to establish target engagement for a therapeutic ketogenic diet (TKD) in AN after weight recovery and establish safety and tolerability. It is hypothesized that TKD will be associated with reduced brain glucose metabolism using [18F]fluorodeoxyglucose ([18F]FDG) and positron emission tomography (PET) (target engagement). Higher blood ketosis levels will be associated with a more significant reduction of the brain [18F]FDG glucose metabolism rate (dose dependency). It is hypothesized that TKD will be well tolerated, that participants will remain within the normal weight range (tolerability), and that study participants will be able to adhere to TKD as indicated by regular blood ketosis measurements (treatment fidelity). There will be an initial indication that TKD and associated biological measures correlate with behavioral measures derived from eating disorder-specific assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- therapeutic ketogenic diet for 14 weeks
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Ketogenic Diet | Experimental | Dietary Supplement: Therapeutic Ketogenic Diet (TKD)Subjects will be placed on a therapeutic ketogenic diet (TKD) for a duration of 14 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Ketogenic Diet (TKD)2 week induction to establish ketosis followed by 12 weeks therapeutic ketogenic diet | Dietary supplement | Therapeutic Ketogenic Diet |
Primary outcome
[18F]fluorodeoxyglucose (FDG) uptake
Time frame: Difference in pre/post Therapeutic Ketogenic Diet PET/CT scans
To test whether TKD will be associated with reduced brain [18F]fluorodeoxyglucose (FDG) uptake
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Ketogenic Diet (TKD) in people with Anorexia Nervosa, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[18F]fluorodeoxyglucose (FDG) uptake (time frame: Difference in pre/post Therapeutic Ketogenic Diet PET/CT scans). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.