Safety and Tolerability of Fat-rich vs. Carbohydrate-rich High-caloric Food Supplements in Patients With Amyotrophic Lateral Sclerosis (ALS)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Adverse Events and Serious Adverse Events
研究概览
简要总结
The LIPCAL-ALS study (NCT02306590) has provided preliminary evidence that a high-caloric nutrition might prolong survival in fast-progressing ALS patients. Since increasing the amount of calories of the intervention might possibly increase the beneficial effect, the investigators seek to investigate whether an ultra-high caloric diet (UHCD), featuring the double amount of calories compared to LIPCAL-ALS, will be well tolerated by ALS patients and may serve as an intervention for a potential LIPCALII study. For this purpose, the investigators will compare two different UHCDs (one fat-rich and one carbohydrate-rich) with regard to safety and tolerability over a time frame of 4 weeks. A third group will receive the original diet from LIPCAL, and a fourth group will receive no intervention (control group).
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
- Single (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
- •Diagnosis of Amyotrophic Lateral Sclerosis (ALS) according to the revised version of the El Escorial criteria (Ludolph et al. 2015)
- •Slope of ALS Functional Rating Scale Revised (ALSFRS-R) of >0.25 points per month at baseline visit based on the formula (48 - score at baseline visit) / (time between date of first symptom and baseline visit)
- •stable on standard therapy riluzole (100 mg/day) for at least 4 weeks
- •capable of thoroughly understanding all information given and giving full informed consent according to good clinical practice (GCP)
排除标准
- •already taking any dietary supplements
- •participation in another clinical trial within the preceding 8 weeks
- •tracheostomy or assisted ventilation of any type which exceeds 23 hours per day
- •pregnancy or breast-feeding females
结局指标
主要结局
Adverse Events and Serious Adverse Events
时间窗: 4 weeks
Incidence of Adverse Events and Serious Adverse Events
Laboratory values
时间窗: 4 weeks
Incidence of abnormalities in clinical laboratory assessments, vital signs and physical examinations
次要结局
- Appetite(2 weeks; 4 weeks)
- Taste of Intervention(2 weeks; 4 weeks)
- Body Weight(2 weeks; 4 weeks)
- Eating Habits(2 weeks; 4 weeks)
- Adverse Events and Serious Adverse Events(6 weeks)
- Biomarkers(4 weeks)
- ALSFRS-R(4 weeks)
研究者
Albert Christian Ludolph, Prof.
Prof. Dr.
University of Ulm