Effects of Isoflavones on Hypertension, Serum Concentrations of Fructoseamine and Advanced Glycated End Products in Peritoneal Dialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- pentosidine
研究概览
简要总结
The aim of this double-blind randomized clinical trial is to determine the effects of isoflavones on serum concentrations of fructoseamine and advanced glycated end products in peritoneal dialysis patients. Forty-four patients from shafa clinic will randomly assign to either isoflavone or placebo group. The patients in isoflavone group will receive 100 mg soy isoflavone (as 2 capsules) daily for 8 weeks, while the placebo group will receive identical placebo. At the baseline and the end of the study,7 ml blood will be collected from each patient after a 12-14-hours fasting and serum concentrations of fructoseamine, carboxymethyl lysine, pentosidine, glucose will be measured. Furthermore, blood pressure measurements will be performed twice with a ten-minute interval between testing
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Continuous Ambulatory Peritoneal Dialysis for 6 months or more Body mass index below 35
排除标准
- •infections inflammatory diseases liver diseases Clinical diagnosis of cancer receiving glucocorticoid and anti-inflammatory drugs receiving isoflavone supplements Constant consumption of soy or foods containing soy in the diet
结局指标
主要结局
pentosidine
时间窗: 8 weeks
Serum concentrations of pentosidine
fructoseamine
时间窗: 8 weeks
Serum concentrations of fructoseamine
carboxymethyl lysine
时间窗: 8 weeks
Serum concentrations of carboxymethyl lysine
Systolic blood pressure
时间窗: 8 weeks
Systolic blood pressure
glucose
时间窗: 8 weeks
Serum concentrations of glucose
Diastolic blood pressure
时间窗: 8 weeks
Diastolic blood pressure
次要结局
未报告次要终点
研究者
zahra yari
Principal Investigator
National Nutrition and Food Technology Institute