An Interventional Study for the Beneficial Effects of Prebiotics on Hyperuricemia in Chinese Subjects
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change of excretion of uric acid
研究概览
简要总结
Hyperuricemia is a major risk factor for many chronic diseases. Recently, dysbiosis of gut microbiota has been reported to play an important role in the pathogenesis of Hyperuricemia. Animal studies have demonstrated that administration of prebiotics help delay the progression of Hyperuricemia through several mechanisms. This trial aims to examine its protective effect in humans.
详细描述
Hyperuricemia is a major risk factor for many chronic diseases. Recently, dysbiosis of gut microbiota has been reported to play an important role in the pathogenesis of hyperuricemia. Animal studies have demonstrated that administration of prebiotics help delay the progression of hyperuricemia through several mechanisms such as reduction in endotoxemia, and enhanced production of short-chain fatty acids.
However, whether administration of prebiotics also has a protective effect in subjects with Hyperuricemia remain unknown.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Local residents aged between 18-65 years old;
- •Stable weight (<5% weight change over last 3 months);
- •Fasting uric acid was > 420μmol/L for male and > 360μmol/L for female on two different days
- •Those who have never taken uric acid lowering drugs or have stopped taking uric acid lowering drugs for at least four weeks;
- •Absence of any diet or medication that might interfere with Uric acid metabolism and gut microbiota, especially antibiotics and probiotics at least 4 weeks before recruitment.
排除标准
- •Acute illness or evidence of any acute or chronic inflammatory of infective diseases;
- •Participation in regular diet program more than 2 times per week in the latest 3 months prior to recruitment;
- •Mental illness rendering them unable to understand the nature, scope, and possible consequences of the study.
- •Women of childbearing age who are pregnant, breast-feeding or preparing for pregnancy; Patients who had surgery within the past six months or planned surgery during the trial period
结局指标
主要结局
Change of excretion of uric acid
时间窗: from baseline to 12 weeks after intervention
excretion rate of uric acid assessed by secretion rate of uric acid in urine during 3 hours
Change of serum Uric acid
时间窗: from baseline to 12 weeks after intervention
change of fasting uric acid level assessed by biochemical detector
次要结局
- Change of Microbial metabolites(from baseline to 12 weeks after intervention)
- Change of Gut microbiota(from baseline to 12 weeks after intervention)
- Change in lipid profiles(from baseline to 12 weeks after intervention)
- Change in blood pressure(from baseline to 12 weeks after intervention)
- Change in fasting glucose(from baseline to 12 weeks after intervention)
- Change in waist circumference(from baseline to 12 weeks after intervention)
研究者
Min Xia
Professor
Sun Yat-sen University