Effect of Low-protein Formula Nutritional Supplements on Renal Function Progression, Muscle Mass and Physical Activity With Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Change of muscle strength
研究概览
简要总结
Prospective randomized contorl study.Comparing clinical outcome between chronic kidney disease who were prescribed 6% low-protein nutrition supplement along with dietatian regular nutrition education and those without oral nutrition supplement.
详细描述
Past studies have shown that supplementation with low-protein nutritional formulas helps to increase compliance with low-protein diet control, but few studies have explored low-protein nutritional formulas supplementing the calories chronic kidney disease patient need, and nutritional supplements rich in ω-3 fatty acids, vitamin D and essential amino acid having effect in chronic renal function and changes in muscle mass, strength, and mobility. The propose of this study that low protein supplement may help maintain renal function or delay deterioration of renal function, or may reduce the risk of malnutrition and further improve muscle strength and mobility or quality of life.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is >65years of age.
- •Subject has been diagnosed with Chronic Kidney Disease (CKD) and is classified as being between Stages 3 to 5.
排除标准
- •The physician determines that the clinical condition is unstable.
- •Lower limb injury or severe edema.
- •food allergies to milk, or fish
- •There is a heart rhythm in the body and a prosthetic device.
- •Those who are unable to complete the questionnaire due to severe cognitive impairment as determined by the physician.
结局指标
主要结局
Change of muscle strength
时间窗: Baseline to 12 weeks and 24 weeks
Hand grip strength
Change of micronutrients intake
时间窗: Baseline to 12 weeks and 24 weeks
24-hour dietary record measurement
Change of Gait speed
时间窗: Baseline to 12 weeks and 24 weeks
Gait speed measurement
Change of 5-meter distance walk
时间窗: Baseline to 12 weeks and 24 weeks
5-meter distance walk measurement
Change of nutrition status
时间窗: Baseline to 12 weeks and 24 weeks
Mini Nutritional Assessment Short-Form score
Change of carbohydrate intake
时间窗: Baseline to 12 weeks and 24 weeks
24-hour dietary record measurement
Change of fat intake
时间窗: Baseline to 12 weeks and 24 weeks
24-hour dietary record measurement
Change of body composition
时间窗: Baseline to 12 weeks and 24 weeks
Using bioelectrical impedance analysis(BIA, Tanita MC-780, Japan)
Change of total energy intake
时间窗: Baseline to 12 weeks and 24 weeks
24-hour dietary record measurement
Change of protein intake
时间窗: Baseline to 12 weeks and 24 weeks
24-hour dietary record measurement
次要结局
- Change of LDL-cholesterol(Baseline to 12 weeks and 24 weeks)
- Change of blood urea nitrogen(Baseline to 12 weeks and 24 weeks)
- Change of calcium(Baseline to 12 weeks and 24 weeks)
- Change of phosphorus(Baseline to 12 weeks and 24 weeks)
- Change of magnesium(Baseline to 12 weeks and 24 weeks)
- Change of Hemoglobin A1c(Baseline to 12 weeks and 24 weeks)
- Change of red blood cell(Baseline to 12 weeks and 24 weeks)
- Change of triglyceride(Baseline to 12 weeks and 24 weeks)
- Change of serum creatinine(Baseline to 12 weeks and 24 weeks)
- Change of estimated glomerular filtration rate(Baseline to 12 weeks and 24 weeks)
- Change of albumin(Baseline to 12 weeks and 24 weeks)
- Change of sodium(Baseline to 12 weeks and 24 weeks)
- Change of White blood cell(Baseline to 12 weeks and 24 weeks)
- Change of daily protein intake.(Baseline to 12 weeks and 24 weeks)
- Change of potassium(Baseline to 12 weeks and 24 weeks)
- Change of hemoglobin(Baseline to 12 weeks and 24 weeks)
- Change of liver function(Baseline to 12 weeks and 24 weeks)
- Change of cholesterol(Baseline to 12 weeks and 24 weeks)
- Change of blood sugar(Baseline to 12 weeks and 24 weeks)
- Change of CRP(Baseline to 12 weeks and 24 weeks)
- Change of hematocrit(Baseline to 12 weeks and 24 weeks)