NCT01016522终止3 期
Safety and Tolerability of the Ketogenic Diet in ALS
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Study will determine if humans with ALS fed a strictly controlled diet designed to generate large amounts of ketones is safe and well-tolerated without evidence of weight loss or other adverse effect
研究概览
简要总结
This research is being done to see if the ketogenic diet (which is high in fat and low in carbohydrates) is safe and tolerable in amyotrophic lateral sclerosis (ALS) patients who are fed through a gastrostomy tube. This is not a study to see if ketogenic diets are effective in the treatment of ALS.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Familial or sporadic ALS diagnosed as probable, laboratory-supported probable or definite according to the World Federation of Neurology El Escorial criteria
- •Age 18 or older
- •Capable of providing informed consent and complying with trial procedures
- •Gastrostomy tube in place for the prior month
- •Appel ALS score less than 100
- •Able to stand on a scale with assistance
- •For patients with Appel ALS scores greater than 80, availability of caregiver who is willing and able to:
- •Prepare, administer and log tube feeds
- •Check and log gastric residuals
- •Assist with weighing subject at home if necessary
- •Willing to chart food intake during the six-month study
- •Patients either not taking Riluzole (Rilutek) or Minocycline or on a stable dose of these for 30 days
- •Not taking Coenzyme Q10 or on a stable dose and brand for 30 days
- •Absence of exclusion criteria
排除标准
- •Forced vital capacity <50% of predicted
- •Dependence on mechanical ventilation for more than 12 hours per day
- •Exposure to any experimental agent within 30 days of onset of this protocol
- •Women who are pregnant or planning to become pregnant
- •Women of childbearing potential not practicing contraception
- •Enrollment in another research study within 30 days of or during this trial
- •Mini-Mental State Exam (MMSE) score <20
- •Patients with symptomatic cardiac disease or hypercholesterolemia
- •Patients with myocardial infarction within 6 months of this trial
- •Renal dysfunction defined as BUN and creatinine >2XULN
- •Known mitochondrial disease
- •Prior use of a 4:1 ketogenic diet or Atkins diet within 1 month of this trial
- •Impaired liver function, defined as AST or ALT of 3 X ULN
- •Patients who have a pacemaker or other internal electronic medical device
结局指标
主要结局
Study will determine if humans with ALS fed a strictly controlled diet designed to generate large amounts of ketones is safe and well-tolerated without evidence of weight loss or other adverse effect
时间窗: 28 weeks
次要结局
- Evaluate changes in motor function, strength, fatigue, body fat and cognitive function(28 weeks)
研究者
Vinay Chaudhry
Professor
Johns Hopkins University
研究点 (2)
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