To Explore the Anti-oxidative Effects and Inflammation Effects of Soy Protein to Renal Function of End Stage Diabetes Nephropathy Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- estimated glomerular filtration rate (eGFR)
研究概览
简要总结
This study investigated the beneficial effects of soybean on the renal function, oxidative stress, and inflammatory responses in patients with end-stage diabetic nephropathy (DN).
详细描述
DN outpatients were recruited from Tung's Taichung MetroHarbor Hospital (Taichung City, Taiwan). They were randomly separated into two groups; one group was given soy protein drink and the other group was given casein drink for 4 months. The blood pressure, plasma glucose, lipid profile, renal function (estimated glomerular filtration rate, eGFR), inflammatory factor levels were analyzed at the baseline and at the end of the study.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged from 40 to 75 years and were at DN stage 4 or 5 were enrolled in this study.
排除标准
- •The exclusion criteria were having hemodialysis, lactose intolerance, gastrointestinal (GI) tract dysfunction, liver disease, acute metabolic acidosis or ketoacidosis, in acute infection, severe dehydration, alcohol abuse, addictive drug abuse, cancer in recent 5 years, being involved in another trial in past 1 month, had operation in the past 4 months, or had compliance lower than 90% in the first month of study.
结局指标
主要结局
estimated glomerular filtration rate (eGFR)
时间窗: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
renal function
creatinine
时间窗: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
renal function
high-sensitivity C-reactive protein (hs-CRP)
时间窗: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
inflammatory indicators
soluble intercellular adhesion molecule (sICAM)-1
时间窗: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
inflammatory indicators
interleukin (IL)-6
时间窗: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
inflammatory indicators
24-hours dietary recall
时间窗: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
Estimated by registered dietitian to understand calories, protein and nutrients intake..
plasma malondialdehyde (MDA)
时间窗: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
Antioxidative statement-lipid peroxidation
soluble vascular cell adhesion molecule (sVICAM)-1
时间窗: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
inflammatory indicators
次要结局
- body weight(Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months)
- blood glucose(Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months)
- Blood pressure(Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months)
- lipid profile(Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months)