Effects of Green Tea on Level of Serum Uric Acid in Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- serum uric acid
研究概览
简要总结
Green tea has been extensively investigated for several potential health benefits. Previous studies have suggested that green tea may lower serum uric acid level in human. The purpose of this study is to investigate uric-lowering properties of green tea in healthy individuals.
详细描述
Elevated serum uric acid is related to the risk of development of gout, the most common inflammatory arthritis in men. Allopurinol, a xanthine oxidase inhibitor, is one of the uric-lowering agents commonly used in patients suffering from recurrent and chronic gout. Nevertheless, its use is limited by adverse effects and serious allergic reaction in some patients.
Green tea is one of the most frequently consumed beverages, particularly in Japan. Green tea contains high level of catechins, in which Epigallocatechin gallate (EGCG) is the most abundant compound among other types of catechins. Antioxidant effect contributes to various potential health benefits of green tea. Several in-vitro studies have found that green tea inhibits xanthine oxidase activity and subsequently decreases reactive oxygen species (ROS) and uric acid production. We therefore would like to investigate the hypouricemic effects of green tea.
The study consists of three periods with a total duration of four weeks. The first week is the control period. The following two weeks is the interventional period and the last week is the follow up period. Thirty healthy participants will be randomly assigned into three experimental groups, receiving 2 gm/day, 4 gm/day and 6 gm/day (in capsule, two times after meal) of green tea extract during interventional period. Blood and urine samples will be taken at the beginning and at the end of each study period.
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
- 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
- 是
入选标准
- •Age 18 years or older
- •Healthy individuals
- •Normal renal and liver function from blood tests
排除标准
- •Presence of co-morbidity or currently ill
- •Currently using any medication or nutritional supplement product that may affect serum uric acid level
- •Serum creatinine higher than 1.5 mg/dl
- •Abnormal serum Aspartate aminotransferase (AST) and/or Alanine transaminase (ALT)
- •Greater than 15% change in serum uric acid during control period
结局指标
主要结局
serum uric acid
时间窗: 4 weeks (prior to, immediately after and 7 days after intervention)
次要结局
- urinary uric acid excretion(4 weeks (prior to, immediately after and 7 days after intervention))
- serum antioxidant activity(4 weeks (prior to, immediately after and 7 days after intervention))
- serum EGCG level(1 week (immediately after and 7 days after intervention))
- Adverse events(4 week (prior to, immediately after and 7 days after intervention))
研究者
Kanon Jatuworapruk
Kanon Jatuworapruk M.D
Chiang Mai University