Phase II Safety and Tolerability Study of High Fat/High Calorie Versus High Calorie Versus Optimal Nutrition in Subjects With Amyotrophic Lateral Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 25
- 主要终点
- Tolerability
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of long-term use of high fat/high calorie and high calorie diets in people with amyotrophic lateral sclerosis (ALS) (Lou Gehrig's disease).
详细描述
Weight loss is a common and severe symptom of amyotrophic lateral sclerosis (ALS), caused both from inadequate calorie intake and an increased metabolic rate. People with ALS are generally instructed to increase their calorie intake; however, the ideal amount and type of calories has not been studied. Several studies in an animal model of motor neuron disease have shown that a high fat/high calorie diet can increase survival by as much as 38%. Mice on a high fat diet also live longer than mice fed diets consisting of high protein or high sugar. We are therefore conducting a phase II safety, tolerability, and preliminary efficacy trial in ALS of high fat versus high calorie versus normal diet. The normal diet will be calculated based on the number of calories needed to replace each participant's measured daily calorie requirement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Clinical diagnosis of ALS
- •Male or female subjects aged 18 years or older
- •Must already be tolerating tube feedings through either a gastrostomy tube (G-tube or PEG) or jejunostomy tube (J-tube)
- •Must require non-invasive ventilation (BIPAP) for less than 10 hours/day
- •Women of childbearing potential must have a negative pregnancy test at screening and be non-lactating.
排除标准
- •History of hepatitis including non-alcoholic steatohepatitis (NASH), cholecystectomy, prior biliary disease such as gallstones
- •History of diabetes
- •History of prior myocardial infarction or stroke
- •Laboratory values: Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.0 times the upper limit of normal or total bilirubin greater than 1.5 times the upper limit of normal
- •Allergy to soy, fish, or milk products
结局指标
主要结局
Tolerability
时间窗: 5 months
Number of participants who completed the study on their assigned study intervention.
Safety Outcomes: Frequency of Adverse Events
时间窗: 5 months
Serious Adverse Events
时间窗: 5 months
SAE were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
次要结局
- Rate of Change in ALSFRS-R in Units/Month(Over 5 months)
- Biomarkers of Body Composition and Lipid Metabolism(5 months follow-up)
研究者
Anne-Marie Alexandra Wills, MD
Assistant Professor of Neurology
Massachusetts General Hospital