Ketogenic Diet in Eating Disorders to Target Metabolism and Normalize Persistent Eating Disorder Psychopathology

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
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• Provision of signed and dated informed consent form

• Stated willingness to comply with all study procedures and availability for the duration of the study

• Persons, aged 18 to 45 years

• History of anorexia nervosa according to DSM-5 criteria

• Weight recovered at the time of study inclusion (body mass index \> 17.5 kg/m2)

• Greater or equal to 2 standard deviations scores of eating disorder-relevant behaviors on the Eating Disorder Inventory-3 and Eating Disorder Examination Questionnaire

• The following types of psychiatric medications are allowed: antidepressant, anxiolytic, atypical antipsychotic, mood stabilizers

• English is primary spoken language

• Provision of signed and dated informed consent form

• Stated willingness to comply with all study procedures and availability for the duration of the study

• Persons, aged 18 to 45 years

• Anorexia nervosa according to DSM-5 criteria

• Current Body Mass Index (BMI) at the time of study inclusion of 16.0 to 17.49

• 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

• Provision of signed and dated informed consent form

• Stated willingness to comply with all study procedures and availability for the duration of the study

• Persons, aged 18 to 45 years

• History of bulimia nervosa 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

Locations
United States
California
University of California San Diego
RECRUITING
San Diego
Contact Information
Primary
Megan Shott, BS
mshott@health.ucsd.edu
848-246-5272
Time Frame
Start Date: 2023-10-03
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 20
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov