Microbial Soy Milk Consumption, Inflammation and Renal Function Among Type 2 Diabetic Patients With Nephropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- serum levels of Neutrophil gelatinase-associated lipocalin (NGAL)
研究概览
简要总结
The aim of the present study was to determine the effects of fortified soy milk with L. planetarium A7 on a cytokine receptor, an adipokine and renal function biomarkers in type II diabetic patients with nephropathy.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 32 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 2 diabetic patients with stages 1 and 2 of nephropathy (defined as meeting criteria including fasting blood glucose >126 mg/dL, hypoglycemic agents, or insulin intake, proteinuria >300 mg/day, and glomerular filtration rate >90 mL/min)
排除标准
- •pregnancy or lactating in women
- •allergy or intolerance to soy milk or avoidance of soy milk consumption
- •smoking, alcoholism
- •recent antibiotic therapy and using of supplements containing vitamins and minerals
- •any medical condition such as inflammatory bowel disease, infection, liver disease and rheumatoid arthritis.
结局指标
主要结局
serum levels of Neutrophil gelatinase-associated lipocalin (NGAL)
时间窗: 8 week
NGAL will determine by commercial sandwich enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's protocols. (Human ELISA kits, Shanghai Crystal Day Biotech Company, China).
cystatin C (Cys- C)
时间窗: 8 week
Cys- C will determine by commercial sandwich enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's protocols. (Human ELISA kits, Shanghai Crystal Day Biotech Company, China).
inflammatory adipokine- Progranulin (PGRN)
时间窗: 8 week
PGRN will determine by commercial sandwich enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's protocols. (Human ELISA kits, Shanghai Crystal Day Biotech Company, China).
cytokine receptor -soluble tumor necrosis factor receptor 1 (sTNFR1),
时间窗: 8 week
sTNFR1 will determine by commercial sandwich enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's protocols. (Human ELISA kits, Shanghai Crystal Day Biotech Company, China).
次要结局
未报告次要终点
研究者
Makan Pourmasoumi
MSc student, Principal Investigator, Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran
Isfahan University of Medical Sciences