Metabolic Diet for Relapse Prevention in Anorexia Nervosa
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percent completion of food
研究概览
简要总结
This is an interventional study that will test the safety, tolerability, and efficacy of the Metabolic Diet, which was designed as a treatment for women with anorexia nervosa to remain weight-stable after they have been restored from low weight. Participants will be adult women with anorexia nervosa who have been recently restored to normal weight and adult women with no history of eating disorders. After enrollment, participants will start meeting weekly with a registered dietitian to implement the Metabolic Diet in their daily lives, and will receive medical monitoring for adherence, side effects, changes in metabolic or psychological parameters, and weight stability.
详细描述
The study plan to enroll a total of 20 subjects from the broader New York City area into an 8-week eating behavioral program. Of the 20, 10 will be weight-restored patients with anorexia nervosa (WR-AN) and the other 10 will be age-, sex-, and body mass index (i.e. weight) matched healthy controls (HC).
The primary study intervention is an eating behavioral program called, Metabolic Diet, which is aimed to change the proportion of macronutrients in their meals to incorporate higher fat content and lower the carbohydrate content to limit fluctuations in circulating blood glucose levels throughout the day, which may contribute to a relapse in anorexia nervosa. Participants will be guided to start the Metabolic Diet following the first 2 individual study visits, and the duration of the primary intervention is for 8 weeks. As part of the intervention, each subject will keep a food log and measure the urinary ketones at home, which they will discuss with the study providers during weekly visits. Each subject will meet individually with the Study Dietician and with the Study Physician on a weekly basis. At these visits, food logs and ketone logs will be reviewed so that subjects' adherence to the Metabolic Diet can be assessed and facilitated.
Surveys and lab work are completed during screening, week 4 and week 8.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age at least 18 and not over 40
- •BMI at or above 18.5 kg/m2
- •Speaks English
- •Medically stable, as cleared by a licensed physician, with vital signs and initial blood draws
- •History of DSM-5 diagnosis of Anorexia Nervosa (WR-AN only)
- •Weight-restored from underweight BMI (under 18.5 kg/m2) within the past 6 months (WR-AN only)
排除标准
- •Current/lifetime diagnosis of DSM-5 psychotic disorders, bipolar disorders
- •Active DSM-5 substance use disorders
- •On medications that could affect metabolism
- •*Subjects are to be free of any medications that could affect metabolism, as discussed with study physician, for 2 weeks prior to primary study visit for glucose function testing.
- •History of suicide attempt within previous 6 months or acute suicide risk
- •Significant current medical illness or metabolic conditions, including diabetes mellitus and pregnancy
- •Current/lifetime diagnosis of DSM-5 eating disorders (HC only)
- •Active DSM-5 depressive disorders (HC only)
结局指标
主要结局
Percent completion of food
时间窗: 10 weeks
Tolerability of intervention will be measured using percent completion of food over 10 weeks. Logs are collected during each of the 8 weekly clinician visits.
Number of adverse events
时间窗: 10 weeks
Safety of intervention will be measured by # of adverse events reported over 10 weeks. Adverse events will be documented during each of the 8 weekly clinician visits.
Percent completion of ketone logs
时间窗: Baseline to 10 weeks
Tolerability of intervention will be measured using percent completion of ketone logs over 10 weeks. Logs are collected during each of the 8 weekly clinician visits.
次要结局
- Change in Weight(Baseline and 10 weeks)
- Changes in Mood using the Quick Inventory of Depressive Symptomatology (QIDS)(Baseline and 10 weeks)
- Changes in aspartate aminotransferase (AST)(Baseline and 10 weeks)
- Changes in Anxiety using the Beck Anxiety Inventory (BAI)(Baseline and 10 weeks)
- Changes in Quality of Life using the Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ) from Baseline to 10 Weeks(Baseline and 10 weeks)
- Changes in Blood Urea Nitrogen (BUN)(Baseline and 10 weeks)
- Changes in Hemoglobin(Baseline and 10 weeks)
- Changes in Total Cholesterol(Baseline and 10 weeks)
- Changes in Triglycerides(Baseline and 10 weeks)
- Changes in albumin(Baseline and 10 weeks)
- Change in Eating Disorder Examination Questionnaire (EDE-Q)(Baseline and 10 weeks)
- Changes in Carbon Dioxide (CO2)(Baseline and 10 weeks)
- Changes in Calcium(Baseline and 10 weeks)
- Changes in Glucose(Baseline and 10 weeks)
- Changes in High density lipoprotein (HDL cholesterol)(Baseline and 10 weeks)
- Changes in Clinical Impairments using the Clinical Impairment Assessment (CIA)(Baseline and 10 weeks)
- Changes in Sodium level(Baseline and 10 weeks)
- Changes in Red Blood Count (RBC)(Baseline and 10 weeks)
- Changes in alanine transaminase (ALT)(Baseline and 10 weeks)
- Changes in Potassium level(Baseline and 10 weeks)
- Changes in Chloride(Baseline and 10 weeks)
- Changes in Creatine(Baseline and 10 weeks)
- Changes in White Blood Count (WBC)(Baseline and 10 weeks)
- Changes in Hematocrit(Baseline and 10 weeks)
- Changes in Platelet(Baseline and 10 weeks)
- Changes in hemoglobin A1c(Baseline and 10 weeks)
- Changes in Low density lipoprotein (LDL cholesterol)(Baseline and 10 weeks)
研究者
Chinara Tate
Clinical Nutrition Coordinator
Icahn School of Medicine at Mount Sinai