Effects of Isoflavones on Cardiovascular Disease Risk Factors, Bone Metabolism Markers, Serum Concentrations of Fructoseamine and Advanced Glycated End Products in Peritoneal Dialysis Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Lp (a)
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 cardiovascular disease risk factors, bone metabolism markers, serum concentrations of fructoseamine and advanced glycated end products in peritoneal dialysis patients. Forty-four patients from shafa clinic and Dr.najafi's 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 Lp (a), MDA, hs-CRP, sICAM-1, bone alkaline phosphatase, osteocalcin, N-telopeptide, osteoprotegerin, RANKL, iPTH, triglyceride, total cholesterol, HDL-C, LDL-C, fructoseamine, carboxymethyl lysine, pentosidine, glucose, albumin, calcium and phosphorous 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; past medical history 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
Lp (a)
时间窗: 8 weeks
Serum concentrations of lipoprotein-a
triglyceride
时间窗: 8 weeks
Serum concentrations of triglyceride
Osteoprotegerin
时间窗: 8 weeks
Serum concentrations of Osteoprotegerin
RANKL
时间窗: 8 weeks
Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand
osteocalcin
时间窗: 8 weeks
Serum concentrations of osteocalcin
N-telopeptide
时间窗: 8 weeks
Serum concentrations of N-telopeptide
hs-CRP
时间窗: 8 weeks
Serum concentrations of high sensitivity c-reactive protein
MDA
时间窗: 8 weeks
Serum concentrations of malondialdehyde
sICAM-1
时间窗: 8 weeks
Serum concentrations of Soluble intercellular adhesion molecule-1
bone alkaline phosphatase
时间窗: 8 weeks
Serum concentrations of bone alkaline phosphatase
total cholesterol
时间窗: 8 weeks
Serum concentrations of total cholesterol
HDL-C
时间窗: 8 weeks
Serum concentrations of High-density lipoprotein cholesterol
LDL-C
时间窗: 8 weeks
Serum concentrations of low-density lipoprotein cholesterol
sVCAM-1
时间窗: 8 weeks
Serum concentrations of Soluble vascular adhesion molecule-1
E-selectin
时间窗: 8 weeks
Serum concentrations of E-selectin
次要结局
- calcium(8 weeks)
- albumin(8 weeks)
- phosphorous(8 weeks)
- iPTH(8 weeks)
研究者
zahra yari
Principal Investigator
National Nutrition and Food Technology Institute