Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06000774
Status:
RECRUITING
Last Update Posted:
2023-10-12
First Post:
2023-08-14
Brief Title:
Therapeutic Ketogenic Diet in Anorexia Nervosa
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Ketogenic Diet in Eating Disorders to Target Metabolism and Normalize Persistent Eating Disorder Psychopathology
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 175 or greater but continue to struggle with eating disorder behaviors including a high drive for thinness and body dissatisfaction
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None