NCT01417312已完成不适用
Metabolic Effects of a Green Tea Extract in Multiple Sclerosis Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Fasting and postprandial lipid oxidation in grams per hour, assessed by indirect calorimetry, after 3 months intake of green tea extract versus placebo
研究概览
简要总结
This study aims to investigate metabolic effects of a standardized green tea extract, containing a defined amount of epigallocatechin-3-gallate (EGCG), in multiple sclerosis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with relapsing-remitting multiple sclerosis
- •stable treatment with glatiramer acetate at least 6 months prior to inclusion
- •Expanded disability status scale < 4.5
- •Normal weight, overweight
排除标准
- •Primary or secondary progressive forms of multiple sclerosis
- •Clinically relevant heart, lung, liver, kidney diseases
- •Habitual caffeine intake over 300 mg per day
- •Habitual consumption of green tea
- •Alcohol or drug abuse
结局指标
主要结局
Fasting and postprandial lipid oxidation in grams per hour, assessed by indirect calorimetry, after 3 months intake of green tea extract versus placebo
时间窗: Three months
次要结局
未报告次要终点
研究者
Friedemann Paul
Prof, MD
Charite University, Berlin, Germany
研究点 (2)
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