Metabolic Diet for Relapse Prevention in Anorexia Nervosa

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Metabolic Diet
  Metabolic Diet includes increasing the amount of foods high in fat and decreasing the amount of foods that may cause increased flux in blood glucose levels. Food logs and ketone logs will be reviewed weekly during the 8 weeks of the intervention.

Первичные конечные точки

• Number of adverse events [Срок оценки: 10 weeks]
• Percent completion of food [Срок оценки: 10 weeks]
• Percent completion of ketone logs [Срок оценки: Baseline to 10 weeks]

Вторичные конечные точки (12)

• Change in Weight [Срок оценки: Baseline and 10 weeks]
• Change in Eating Disorder Examination Questionnaire (EDE-Q) [Срок оценки: Baseline and 10 weeks]
• Changes in Anxiety using the Beck Anxiety Inventory (BAI) [Срок оценки: Baseline and 10 weeks]
• Changes in Mood using the Quick Inventory of Depressive Symptomatology (QIDS) [Срок оценки: Baseline and 10 weeks]
• Changes in Clinical Impairments using the Clinical Impairment Assessment (CIA) [Срок оценки: Baseline and 10 weeks]
• Changes in Quality of Life using the Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ) from Baseline to 10 Weeks [Срок оценки: Baseline and 10 weeks]
• Changes in Carbon Dioxide (CO2) [Срок оценки: Baseline and 10 weeks]
• Changes in Potassium level [Срок оценки: Baseline and 10 weeks]
• Changes in Sodium level [Срок оценки: Baseline and 10 weeks]
• Changes in Chloride [Срок оценки: Baseline and 10 weeks]
• Changes in Calcium [Срок оценки: Baseline and 10 weeks]
• Changes in Creatine [Срок оценки: Baseline and 10 weeks]

Критерии участия

Критерии включения

• Female
• 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)

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Icahn School of Medicine at Mount Sinai — New York

Идентификаторы

NCT: NCT05197309 · STUDY-20-01956

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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