The Effect of Vinegar Consumption on 24-hour Urinary Risk Factors Associated With Calcium Oxalate Urinary Stone Formation: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change of 24-hour urinary risk factors associated with calcium oxalate urinary stone formation
研究概览
简要总结
Purpose:
The aim of this present study is to investigate the effect of vinegar consumption on 24-hour urinary risk factors associated with calcium oxalate urinary stone formation and blood biochemical parameters.
Methods:
The investigators will recruit 50 healthy young student volunteers in this study. By simple random sampling technique, volunteers will be allocated to two groups (group 1, control group; group 2, vinegar group).Each participant in vinegar group drink 15ml vinegar ( Ninghuafu, Sanxi, China) at noon and evening respectively for a period of four weeks.The end point of this study is comparison the outcomes of 24-hour urine and blood biochemical parameters between different group and point-in-time.
详细描述
Purpose:
The written history of vinegar use in China was more than 5,000 years,and it was used as health care products since ancient times. In addition of the main component of acetic acid, it also contains other acids, esters, polyphenols and other active substances.Previous studies have reported some effects of vinegar, such as delays gastric emptying,relieves fatigue, regulates blood glucose and lipid metabolism, antioxidant, reduces blood pressure and so on. The China national epidemiological study of urolithiasis which was conducted from May 2013 through July 2014 indicated that vinegar may be protective against the formation of urolithiasis (has not been published). Animal experiments showed that vinegar could inhibit oxalate calcium crystal formation in rat kidneys (has not been published). Consequently, we performed this randomized controlled trial to investigate the effect of vinegar consumption on 24-hour urinary risk factors associated with calcium oxalate urinary stone formation and blood biochemical parameters.
Methods:
Study design and participants: We will recruit 50 healthy young student volunteers in this study. The inclusion criteria are male who age 18-35 years, and those with normal renal function,without urolithiasis and congenital urinary tract abnormalities. The exclusion criteria include hematuria, urinary tract infection and have a history of kidney or urinary diversion. We exclude male older than 35 years because usually they have to work and not easy to collect 24-hour sample. The reason of excluding female is that the trail will last four weeks and women's menstrual cycle could affect 24-hour urine collection.
Randomisation:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Normal renal function.
- •Those without urolithiasis
- •Those without congenital urinary tract abnormalities.
排除标准
- •Those with hematuria
- •Those with urinary tract infection
- •Those have a history of kidney or urinary diversion.
结局指标
主要结局
Change of 24-hour urinary risk factors associated with calcium oxalate urinary stone formation
时间窗: One day before drinking vinegar(the 0th day)and on the 7th,14th,21th and 28th day after drinking vinegar.
To compare the change of 24-hour urinary risk factors associated with calcium oxalate urinary stone formation which include Ph, volume, creatinine, oxalate, citrate, phosphate, uric acid, calcium, magnesium, sodium and chloride of 24-hour urine between two groups on the 7th,14th,21th and 28th day after drinking vinegar.
次要结局
- Change of blood biochemical parameters(One day before drinking vinegar(the 0th day)and on the 29th day after drinking vinegar.)
研究者
Guohua Zeng
Vice President of the Hospital
The First Affiliated Hospital of Guangzhou Medical University