Therapeutic Ketogenic Diet in Anorexia Nervosa

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT06000774
Status
Recruiting
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Conditions

  • Anorexia Nervosa
  • Anorexia Nervosa in Remission
  • Bulimia Nervosa

Eligibility Criteria

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

Interventions

  • Therapeutic Ketogenic Diet — OTHER
    therapeutic ketogenic diet

Study Details

This study will investigate the effects of therapeutic ketogenic diet (TKD) on eating behavior including drive to restrict, body dissatisfaction, mood and anxiety in individuals with anorexia nervosa who have been weight normalized (body mass index of 17.5 or greater) but continue to struggle with eating disorder behaviors including a high drive for thinness and body dissatisfaction. The Underweight Anorexia Nervosa (AN) Sub-Study will investigate the effects of TKD on eating behavior including drive to restrict, body dissatisfaction, mood and anxiety in individuals with anorexia nervosa who are currently underweight (body mass index between 16.0 and 17.49) and continue to struggle with eating disorder behaviors including a high drive for thinness and body dissatisfaction. The Bulimia Nervosa Pilot will will investigate the effects of TKD on eating behavior including drive to binge and purge, body dissatisfaction, mood and anxiety in individuals with bulimia nervosa.

Key Dates

Start date
Oct 3, 2023
Status verified
Aug 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Therapeutic Ketogenic Diet
    A 2-week therapeutic ketogenic diet (TKD) induction will be implemented to establish nutritional ketosis (the goal are BHB blood levels of 0.5-3.0 millimoles per liter \[mmol/L\]). After establishing the ketotic state, study participants will continue TKD for 12 weeks.

Primary Outcome Measure

To assess the safety and tolerability in individuals with anorexia nervosa who are weight recovered, individuals with anorexia nervosa who are currently underweight, and individuals with bulimia nervosa 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 E Shott, BS
[email protected]
858-246-5272
Guido Frank, MD
[email protected]
Guido Frank, MD (PRINCIPAL_INVESTIGATOR)

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