Ketogenic Diet in Eating Disorders to Target Metabolism and Normalize Persistent Eating Disorder Psychopathology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
For the BN Pillot study we will also complete a small pilot in 5 individuals with bulimia nervosa.
For the Underweight Anorexia Nervosa (AN) Sub-Study we will also recruit 30 individuals with anorexia nervosa who are mild to moderately underweight and have a body mass index of between 16.0 to 17.49.
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.
Bulimia Nervosa Pilot Objective 1: To test the effects of ketogenic diet in individuals with bulimia nervosa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Weight-Recovered AN
排除标准
- •Pregnancy or lactation
- •Electrolyte, blood count, kidney function or liver function abnormalities
- •Neurocognitive disorders including dementias or traumatic brain injury that is symptomatic
- •Current alcohol use disorder (AUD) or substance use disorder (SUD) according to DSM-5 criteria
- •Uncontrolled hypertension
- •Hepatic impairment (Class-Pugh b or c)
- •Diabetes mellitus
- •Family history of porphyria
- •History of recent heart attack, vascular disease, or any other current acute medical conditions as determined by the principal investigator
- •Inability or unwillingness to adhere to the TKD diet for the duration of the study
- •Blind or illiterate individuals
- •Underweight AN Sub-Study Inclusion Criteria:
- •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
- •Underweight AN Sub-Study Exclusion Criteria:
- •Pregnancy or lactation
- •Electrolyte, blood count, kidney function or liver function abnormalities
- •Neurocognitive disorders including dementias or traumatic brain injury that is symptomatic
- •Current alcohol use disorder (AUD) or substance use disorder (SUD) according to DSM-5 criteria
- •Uncontrolled hypertension
- •Hepatic impairment (Class-Pugh b or c)
- •Diabetes mellitus
- •Family history of porphyria
- •History of recent heart attack, vascular disease, or any other current acute medical conditions as determined by the principal investigator
- •Inability or unwillingness to adhere to the TKD diet for the duration of the study
- •Blind or illiterate individuals
- •Bulimia Nervosa Pilot Inclusion Criteria:
- •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
- •Bulimia Nervosa Pilot Exclusion Criteria:
- •Pregnancy or lactation
- •Electrolyte, blood count, kidney function or liver function abnormalities
- •Neurocognitive disorders including dementias or traumatic brain injury that is symptomatic
- •Current alcohol use disorder (AUD) or substance use disorder (SUD) according to DSM-5 criteria
- •Uncontrolled hypertension
- •Hepatic impairment (Class-Pugh b or c)
- •Diabetes mellitus
- •Family history of porphyria
- •History of recent heart attack, vascular disease, or any other current acute medical conditions as determined by the principal investigator
- 另有 2 项未显示
结局指标
主要结局
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
时间窗: 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
时间窗: At baseline
In order to identify potential genetic signatures that may predict response to treatment, Whole Exome Sequencing will be conducted on participants.
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.
时间窗: 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 (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
时间窗: 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
时间窗: 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
时间窗: At baseline
In order to identify potential genetic signatures that may predict response to treatment, Whole Exome Sequencing will be conducted on participants.
次要结局
未报告次要终点
研究者
Guido Frank
Professor
University of California, San Diego