Anorexia NervosaNCT06605027
Therapeutic Ketogenic Diet in Partial Hospital Program (PHP) Anorexia Nervosa
A study testing Therapeutic Ketogenic Diet in people with Anorexia Nervosa, run by University of California, San Diego at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Therapeutic Ketogenic Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Provision of signed and dated informed consent form/parental permission form
- Provision of signed and dated assent form if the subject is a minor
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Persons, aged 16 to 45 years
- Current anorexia nervosa diagnosis according to DSM-5 criteria
- An elevated EDE-Q global score of 2.09 or greater
- The following types of psychiatric medications are allowed: antidepressant, anxiolytic, atypical antipsychotic, mood stabilizers
- English is primary spoken language
Who cannot join
- Pregnancy or lactation
- Electrolyte, blood count, kidney function or liver function abnormalities
- Psychosis
- Neurocognitive disorders including dementias or traumatic brain injury that is symptomatic
- Current alcohol use disorder (AUD) or substance use disorder (SUD) according to DSM-5 criteria
- Uncontrolled hypertension
Show all 12Show fewer
- Hepatic impairment (Class-Pugh b or c)
- Diabetes mellitus
- Family history of porphyria
- History of recent heart attack, vascular disease, or any other current acute medical conditions as determined by the principal investigator
- Inability or unwillingness to adhere to the TKD diet for the duration of the study
- Blind or illiterate individuals
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
San Diego, California, 92121
About this study
Official title: 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.
Read the 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.
- Conditions
- Anorexia Nervosa
- Being tested
- Therapeutic Ketogenic Diet
- 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 DietOther
2 week induction to establish ketosis followed by 12 weeks therapeutic ketogenic diet
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Ketogenic Diet (TKD) Study Arm | Experimental | 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. Receives: Other: Therapeutic Ketogenic Diet |
| Treatment as Usual (TAU) Study Arm | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Weekly weights will be obtained to assess whether subjects remain within the clinical goal weight range.
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start1 Jan 2027 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Why it stopped: Unable to start recruitment due to logistical issues working with recruitment program.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be given the option to participate in the study intervention or continue to receive standard of care treatment in a structured high level of care eating disorders program.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
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
- NCT06605027
- Sponsor's protocol ID
- 810945
- Status last verified
- Jul 2026
- First submitted
- 6 Sep 2024
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Calabrese L, Scolnick B, Zupec-Kania B, Beckwith C, Costello K, Frank GKW. Ketogenic diet and ketamine infusion treatment to target chronic persistent eating disorder psychopathology in anorexia nervosa: a pilot study. Eat Weight Disord. 2022 Dec;27(8):3751-3757. doi: 10.1007/s40519-022-01455-x. Epub 2022 Aug 23.
PubMed 35997954Dignon A, Beardsmore A, Spain S, Kuan A. 'Why I won't eat': patient testimony from 15 anorexics concerning the causes of their disorder. J Health Psychol. 2006 Nov;11(6):942-56. doi: 10.1177/1359105306069097.
PubMed 17035265Frank GKW, Shott ME, DeGuzman MC. The Neurobiology of Eating Disorders. Child Adolesc Psychiatr Clin N Am. 2019 Oct;28(4):629-640. doi: 10.1016/j.chc.2019.05.007. Epub 2019 Jul 4.
PubMed 31443880Scolnick B, Zupec-Kania B, Calabrese L, Aoki C, Hildebrandt T. Remission from Chronic Anorexia Nervosa With Ketogenic Diet and Ketamine: Case Report. Front Psychiatry. 2020 Jul 30;11:763. doi: 10.3389/fpsyt.2020.00763. eCollection 2020.
PubMed 32848935
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06605027
- Acronym / sponsor ID
- 810945
- Conditions
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to start recruitment due to logistical issues working with recruitment program.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 20 Sep 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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be given the option to participate in the study intervention or continue to receive standard of care treatment in a structured high level of care eating disorders program.
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Ketogenic Diet (TKD) Study Arm | Experimental | Other: Therapeutic Ketogenic DietParticipants 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. |
| Treatment as Usual (TAU) Study Arm | No intervention | –Participants who consent to be in the Treatment as Usual Study Arm will complete weekly weight and ketone measurements and questionnaires for 14 weeks. |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Provision of signed and dated informed consent form/parental permission form
- Provision of signed and dated assent form if the subject is a minor
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Persons, aged 16 to 45 years
- Current anorexia nervosa diagnosis according to DSM-5 criteria
Key exclusion criteria (12 listed)
- Pregnancy or lactation
- Electrolyte, blood count, kidney function or liver function abnormalities
- Psychosis
- Neurocognitive disorders including dementias or traumatic brain injury that is symptomatic
- Current alcohol use disorder (AUD) or substance use disorder (SUD) according to DSM-5 criteria
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 Diet2 week induction to establish ketosis followed by 12 weeks therapeutic ketogenic diet | Other | Therapeutic Ketogenic Diet (TKD) Study Arm |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Background: PubMed 35997954Calabrese L, Scolnick B, Zupec-Kania B, Beckwith C, Costello K, Frank GKW. Ketogenic diet and ketamine infusion treatment to target chronic persistent eating disorder psychopathology in anorexia nervosa: a pilot study. Eat Weight Disord. 2022 Dec;27(8):3751-3757. doi: 10.1007/s40519-022-01455-x. Epub 2022 Aug 23.
- Background: PubMed 17035265Dignon A, Beardsmore A, Spain S, Kuan A. 'Why I won't eat': patient testimony from 15 anorexics concerning the causes of their disorder. J Health Psychol. 2006 Nov;11(6):942-56. doi: 10.1177/1359105306069097.
- Background: PubMed 31443880Frank GKW, Shott ME, DeGuzman MC. The Neurobiology of Eating Disorders. Child Adolesc Psychiatr Clin N Am. 2019 Oct;28(4):629-640. doi: 10.1016/j.chc.2019.05.007. Epub 2019 Jul 4.
- Background: PubMed 32848935Scolnick B, Zupec-Kania B, Calabrese L, Aoki C, Hildebrandt T. Remission from Chronic Anorexia Nervosa With Ketogenic Diet and Ketamine: Case Report. Front Psychiatry. 2020 Jul 30;11:763. doi: 10.3389/fpsyt.2020.00763. eCollection 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 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 8 inclusion and 12 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: withdrawn, as of the sponsor's last update on 3 Aug 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06605027, which also lists 4 linked publications.
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 3 Aug 2026; AzTrials last refreshed its copy on 1 Nov 2026.