Therapeutic Ketogenic Diet in Anorexia Nervosa
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|ClinicalTrials.gov Identifier: NCT06000774|
Recruitment Status : Recruiting
First Posted : August 21, 2023
Last Update Posted : October 12, 2023
|Condition or disease||Intervention/treatment||Phase|
|Anorexia Nervosa in Remission||Other: Therapeutic Ketogenic Diet||Not Applicable|
For this 14-week study, the investigator will recruit twenty individuals with anorexia nervosa who have been weight normalized but continue to have high impairment from the illness with a high (2 standard deviations above average) drive for thinness and body dissatisfaction and a high drive for food restriction and thus are at high risk for full relapse. Study participants will be carefully assessed and oriented to the ketogenic diet according to the procedures in our small previous trial (Calabrese, et al., 2022). The study will be conducted in a university medical environment, showing feasibility and safety in a typical medical setting. A commercial supplier will provide the ketogenic diet. After ketosis induction over two weeks, study participants will be assessed weekly for ketosis and mood, anxiety, and eating disorder symptoms.
Primary Objective 1 is to test the effects of ketogenic diet in individuals with anorexia nervosa who are weight recovered but continue to suffer severely from drive for thinness and are at very high relapse risk. Participants will be evaluated for tolerability of the study and weight trajectory. Primary Objective 2 is to assess improvement in AN symptoms and behaviors in relation to the ketogenic diet over a 12-week course. Participants will be assessed for specific symptoms such as drive for thinness and body dissatisfaction, fear of eating and weight gain. Primary Objective 3 is to assess the underlying genetic basis for the treatment effect of the ketogenic diet.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Subjects will complete a 14-week therapeutic ketogenic diet (TKD)|
|Masking:||None (Open Label)|
|Official Title:||Ketogenic Diet in Weight Recovered Anorexia Nervosa to Target Metabolism and Normalize Persistent Eating Disorder Psychopathology|
|Actual Study Start Date :||October 3, 2023|
|Estimated Primary Completion Date :||September 30, 2024|
|Estimated Study Completion Date :||March 31, 2025|
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.
Other: Therapeutic Ketogenic Diet
therapeutic ketogenic diet
- To assess the safety and tolerability in individuals with anorexia nervosa who are weight recovered 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 a normal weight range.
- To assess the safety and tolerability in individuals with anorexia nervosa who are weight recovered using the Committee of Clinical Investigations UKU-Side Effect Scale [ Time Frame: At weeks 4, 8, 12, 14 ]The UKU assesses psychiatric, neurologic, autonomic, and other side effects.
- 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 [ Time Frame: At baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 3 month 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, Eating Restraint, and Weight Concern scales have a range of 0 to 6 where higher scores mean worse outcome.
- Measurement of the relationship between genotype and improvement of eating disorder symptoms [ Time Frame: At baseline ]In order to identify potential genetic signatures that may predict response to treatment, Whole Exome Sequencing will be conducted on participants.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06000774
|Contact: Megan Shott, BSfirstname.lastname@example.org|
|United States, California|
|University of California San Diego||Recruiting|
|San Diego, California, United States, 92121|
|Contact: Megan E Shott, BS 858-246-5272 email@example.com|
|Contact: Guido Frank, MD firstname.lastname@example.org|
|Principal Investigator: Guido Frank, MD|
|Principal Investigator:||Guido Frank, MD||University of California, San Diego|