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

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT06605027
Status
Not Yet Recruiting

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Conditions

  • Anorexia Nervosa

Eligibility Criteria

Sex
ALL
Age
16 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Therapeutic Ketogenic Diet — OTHER
    2 week induction to establish ketosis followed by 12 weeks therapeutic ketogenic diet

Study Details

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.

Key Dates

Start date
Jan 1, 2027
Status verified
Apr 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San DiegoSan DiegoCalifornia92121
Megan Shott, BS
[email protected]
858-246-5272
Guido Frank, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of California San Diego· San Diego, CA

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