Therapeutic Ketogenic Diet in Partial Hospital Program (PHP) Anorexia Nervosa

July 30, 2026 updated by: Guido Frank, University of California, San Diego

Therapeutic Ketogenic Diet to Treat Anorexia Nervosa-Specific Cognitions and Behaviors - Currently Ill Individuals in PHP Level of Care and Comparison With Standard of Care

This will be a 14-week longitudinal study with an open design. A total of 120 individuals will be recruited for an end goal of 60 individuals with anorexia nervosa (AN) who are currently in high level of care treatment at the UCSD Eating Disorder Center partial hospital program (PHP) or intensive outpatient (IOP). Forty individuals will be recruited to the TKD and 20 will be treated with treatment as usual with respect to food intake. The age range will be between 16 and 45 years. All study participants will be carefully assessed and will complete rater and self-assessments at the being at the end of the study period. While in the treatment program, the TKD group will receive catered ketogenic meals via a meal service. After discharging from program, participants will have the option to continue with the meal service or cook for themselves. After establishing ketosis, study participants will continue TKD for 12 weeks. All study participants will be followed over three, six, and twelve months after enrolling in the study, whether initiating TKD or being in the treatment as usual arm. This follow-up procedure will help determine whether symptom improvement is stable or worsens in individuals who choose to continue or discontinue the TKD intervention and in relation to the control group. After ketosis induction over two weeks, study participants will be assessed weekly for ketosis and mood, anxiety, and eating disorder symptoms over twelve weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

For this 14-week study, 60 individuals with anorexia nervosa (AN) who are currently in high level of care treatment at the UC San Diego Health Eating Disorders Center for Treatment and Research (UC San Diego Health EDC) partial hospitalization program (PHP) or IOP will be recruited. These individuals will be underweight or recently weight-restored and continue to have high impairment from the illness as indicated by an Eating Disorder Examination Questionnaire (EDE-Q) global score greater than 2.09.

Of those 60 participants, 40 of them will participate in the Therapeutic Ketogenic Diet (TKD) Study Arm and 20 subjects will be enrolled in the Treatment as Usual Study Arm. The study will be conducted in a university medical environment, showing feasibility and safety in a typical medical setting.

After completing the screening steps all participants will complete a blood draw and genetics testing.

AN subjects will be given the option to participate in the TKD Study Arm or the Treatment as Usual Study Arm. Recruitment in each arm will continue until the end recruitment enrollment goal for each arm has been reached. Subjects will not be randomized to the study arm and will be given a choice of what arm they want to participate in. Subjects who consent to be in the TKD Study Arm will complete 14 weeks of therapeutic ketogenic diet (TKD), weekly weight and ketone measurements, weekly behavioral assessments, and meetings with the study doctor and dietician every week, and peer counseling sessions. While in the treatment program, the TKD group will receive catered ketogenic meals via a meal service. After discharging from program, participants will have the option to continue with the meal service or cook for themselves.

AN subjects who consent to be in the Treatment as Usual Study Arm will complete weekly weight and ketone measurements and questionnaires for 14 weeks.

After discharge from the PHP program, subjects will continue to be monitored virtually for the study procedures.

In the last week of the therapeutic ketogenic diet (week 14), all AN subjects will complete another blood draw and the exit visit with the study doctor and dietician.

AN subjects will complete follow-up visits 3 months, 6 months, and 1 year after the 14-week completion date.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92121
        • University of California San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Provision of signed and dated informed consent form/parental permission form
  2. Provision of signed and dated assent form if the subject is a minor
  3. Stated willingness to comply with all study procedures and availability for the duration of the study
  4. Persons, aged 16 to 45 years
  5. Current anorexia nervosa diagnosis according to DSM-5 criteria
  6. An elevated EDE-Q global score of 2.09 or greater
  7. The following types of psychiatric medications are allowed: antidepressant, anxiolytic, atypical antipsychotic, mood stabilizers
  8. English is primary spoken language

Exclusion Criteria:

  1. Pregnancy or lactation
  2. Electrolyte, blood count, kidney function or liver function abnormalities
  3. Psychosis
  4. Neurocognitive disorders including dementias or traumatic brain injury that is symptomatic
  5. Current alcohol use disorder (AUD) or substance use disorder (SUD) according to DSM-5 criteria
  6. Uncontrolled hypertension
  7. Hepatic impairment (Class-Pugh b or c)
  8. Diabetes mellitus
  9. Family history of porphyria
  10. History of recent heart attack, vascular disease, or any other current acute medical conditions as determined by the principal investigator
  11. Inability or unwillingness to adhere to the TKD diet for the duration of the study
  12. Blind or illiterate individuals

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Therapeutic Ketogenic Diet (TKD) Study Arm
Participants in the TKD Study Arm will complete 14 weeks of therapeutic ketogenic diet (TKD), weekly weight and ketone measurements, weekly behavioral assessments, and meetings with the study doctor and dietician every week, and peer counseling sessions.
Other: Therapeutic Ketogenic Diet
2 week induction to establish ketosis followed by 12 weeks therapeutic ketogenic diet
No Intervention: Treatment as Usual (TAU) Study Arm
Participants who consent to be in the Treatment as Usual Study Arm will complete weekly weight and ketone measurements and questionnaires for 14 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To assess the safety and tolerability in individuals with anorexia nervosa who are in a high level of eating disorder treatment using weekly body weight measurements.
Time Frame: Weekly for the duration of the study intervention (14 weeks)
Weekly weights will be obtained to assess whether subjects remain within the clinical goal weight range.
Weekly for the duration of the study intervention (14 weeks)
To assess the safety and tolerability in individuals with anorexia nervosa who are in high level of eating disorder treatment using the Committee of Clinical Investigations UKU-Side Effect Scale (UKU Side Effect Rating Scale)
Time Frame: At weeks 4, 8, 12
The UKU Side Effect Rating Scale assesses psychic, neurologic, autonomic, and other side effects on a scale of 0 to 3 where 0 = not or doubtfully present, 1 = present to a mild degree, 2 = present to a moderate degree, 3 = present to a severe degree. The global score ranges from 0 to 48 where a higher score indicates more side effects of the study intervention.
At weeks 4, 8, 12
Measurement of drive for weight loss, fear of weight gain and body image distortion using the Eating Disorder Examination Questionnaire (EDEQ) Global Score
Time Frame: At baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 3 month follow-up, 6 month follow-up, 1 year follow-up
The Eating Disorders Examination Questionnaire a self report assessment that measures core eating disorder symptoms. Subjects will complete this measure at the beginning and end of the study and weekly throughout the 14-week intervention and the investigator will measure the change in scores. The EDE Global scale has a range of 0 to 6 where higher scores mean worse outcome.
At baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 3 month follow-up, 6 month follow-up, 1 year follow-up
Measurement of drive for weight loss, fear of weight gain and body image distortion using the Eating Disorder Examination Questionnaire (EDEQ) Eating Restraint Score
Time Frame: At baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 3 month follow-up, 6 month follow-up, 1 year follow-up
The Eating Disorders Examination Questionnaire a self report assessment that measures core eating disorder symptoms. Subjects will complete this measure at the beginning and end of the study and weekly throughout the 14-week intervention and the investigator will measure the change in scores. The EDE Restraint scale has a range of 0 to 6 where higher scores mean worse outcome.
At baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 3 month follow-up, 6 month follow-up, 1 year follow-up
Measurement of drive for weight loss, fear of weight gain and body image distortion using the Eating Disorder Examination Questionnaire (EDEQ) Weight Concern Score
Time Frame: At baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 3 month follow-up, 6 month follow-up, 1 year follow-up
The Eating Disorders Examination Questionnaire a self report assessment that measures core eating disorder symptoms. Subjects will complete this measure at the beginning and end of the study and weekly throughout the 14-week intervention and the investigator will measure the change in scores. The EDE Weight concern scale has a range of 0 to 6 where higher scores mean worse outcome.
At baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 3 month follow-up, 6 month follow-up, 1 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 810945

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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