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临床试验/NCT01417312
NCT01417312已完成不适用

Metabolic Effects of a Green Tea Extract in Multiple Sclerosis Patients

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
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

研究组 & 干预措施

Green tea extract

Active Comparator

干预措施: Capsules with 160 mg Teavigo (at least 94% EGCG) (Dietary Supplement)

Placebo

Placebo Comparator

干预措施: Placebo (Dietary Supplement)

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Friedemann Paul

Prof, MD

Charite University, Berlin, Germany

研究点 (1)

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