Therapeutic Ketogenic Diet in Anorexia Nervosa
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of California, San Diego
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pregnancy or lactation
Electrolyte, blood count, kidney function or liver function abnormalities
Psychosis
Neurocognitive disorders including dementias or traumatic brain injury that is symptomatic
Trial design
Design model
Single group
Treatments tested in this trial
Therapeutic Ketogenic Diet
Other interventiontherapeutic ketogenic diet
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Therapeutic Ketogenic DietExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Weekly weights will be obtained to assess whether subjects remain within a normal weight range.
Time frame
Weekly for the duration of the study intervention (14 weeks)2
To assess the safety and tolerability in individuals with anorexia nervosa (AN) who are weight recovered, AN individuals who are currently underweight, and Bulimia Nervosa individuals using the Committee of Clinical Investigations UKU-Side Effect Scale
The UKU assesses psychiatric, neurologic, autonomic, and other side effects.
Time frame
At weeks 4, 8, 12, 143
Measurement of drive for weight loss, fear of weight gain and body image distortion using the Eating Disorder Examination Questionnaire (EDEQ) Global Score, EDEQ Eating Restraint Score, and EDEQ Weight Concern
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, Eating Restraint, and Weight Concern scales have a range of 0 to 6 where higher scores mean worse outcome.
Time frame
At baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 3 month follow-up4
Measurement of the relationship between genotype and improvement of eating disorder symptoms
In order to identify potential genetic signatures that may predict response to treatment, Whole Exome Sequencing will be conducted on participants.
Time frame
At baselineSponsors and contacts
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Source ClinicalTrials.gov