Starving for Energy - A Pilot Study to Test Ketone Derived Energy in Eating Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Eating Disorders Inventory 3 (EDI-3) Body Dissatisfaction Subscale
研究概览
简要总结
This study will investigate the effects of ketone supplementation on eating behavior including drive to binge eat or restrict, mood and anxiety in individuals with anorexia or bulimia nervosa. In addition, the investigators will contrast the effects of active ketone supplementation versus placebo on electroencephalogram (EEG) measurement. All subjects enrolled in the study will undergo EEG on two consecutive days at the beginning of the study, after active ketone supplementation or placebo drink, matched in taste to the ketone drink. Days will be randomized. Thereafter, all subjects will take the ketone supplementation drink for two weeks, twice daily.
详细描述
The goals of the study are:
1) to test the effect of BHB as a nutritional supplement for AN and BN and 2) to test the ingestion of BHB on brain function.
Subjects will complete a battery of self-assessments and a diagnostic assessment in order to determine eligibility and for characterization of behavior to be used in later analyses. After eligibility is confirmed, subjects will complete 2 EEG scans on separate days after ingestion of Ketone supplement drink or placebo and will complete a taste reward task during the EEG scan. Subjects will then complete 2 weeks of daily ketone supplementation and self-assessments.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must currently meet DSM-5 criteria for Anorexia Nervosa, Bulimia Nervosa, or OSFED Anorexia or Bulimia Nervosa based on the MINI diagnostic interview
- •Be medically stable as assessed by a comprehensive medical and behavioral evaluation conducted by a study physician
- •English as primary spoken language.
- •Ability to respond to EMA questions up to 6x per day within 60 minutes of receiving the message.
排除标准
- •Psychotic illness/other organic brain syndromes, dementia, somatization disorders or conversion disorders
- •Current substance abuse or dependence in the past 3 months
- •Physical conditions (e.g., diabetes mellitus, pregnancy) known to influence eating or weight
- •Medical conditions associated with ketoacidosis: type 1 diabetes mellitus, acute pancreatitis, alcoholic gastritis, peptic ulcer disease, hepatitis or Boerhaave syndrome (esophageal rupture)
- •History of significant head trauma
- •Indication of intellectual disability or autism spectrum disorder
- •Known allergy to any of the KenetikR drink components: D-beta-hydroxybutyric acid (D-BHB), Stevia, Monkfruit, Potassium Bicarbonate, Sodium Bicarbonate Potassium Sorbate or Taste Task Solutions: Sucrose, Potassium Chloride, Sodium bicarbonate.
研究组 & 干预措施
Ketone Supplementation
Subjects will ingest 2 daily doses of Kenetik ketone drink supplementation for 14 days.
干预措施: Kenetik Ketone Drink (Dietary Supplement)
结局指标
主要结局
Eating Disorders Inventory 3 (EDI-3) Body Dissatisfaction Subscale
时间窗: Change from baseline to study completion, up to 2 weeks
The Eating Disorders Inventory 3 is a self report assessment that measures core eating disorder symptoms. Subjects will complete this measure at the beginning and end of the study and the investigator will measure the change in scores. The Drive for Thinness Subscale has a range of 0 to 40 where higher scores mean worse outcome.
Eating Disorders Inventory 3 Drive for Thinness Subscale
时间窗: Change from baseline to study completion, up to 2 weeks
The Eating Disorders Inventory 3 is a self report assessment that measures core eating disorder symptoms. Subjects will complete this measure at the beginning and end of the study and the investigator will measure the change in scores. The Drive for Thinness Subscale has a range of 0 to 28 where higher scores mean worse outcome.
Weight Change
时间窗: Change in body mass index from baseline to study completion, up to 2 weeks]
Body Mass Index over time as a measure of food intake from the start to end of the study
次要结局
未报告次要终点
研究者
Guido Frank
Professor
University of California, San Diego