NCT05330663已完成不适用
High Energy Low Protein Renal Formula as Meal Replacement in Predialysis CKD Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change of body weight
研究概览
简要总结
A high energy and low protein renal formula tailored for the specific needs of pre-dialysis CKD patients.
详细描述
Previous studies indicated that low-protein formula nutritional supplements may improve compliance with an LPD and are beneficial in the management of pre-dialysis CKD patients
This study will evaluate the suitability of the disease-specific enteral formula Fresubin® renal in predialysis chronic kidney disease patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic kidney disease stage 4-5 (eGFR <30 mL/min/1.73m2)
- •Age: 20-80 years
- •Patients on low protein diet (0.6-0.8 g protein/kg/d) for at least 3 months
- •Written informed consent
排除标准
- •Dialysis or planned start of dialysis within next 3 months
- •Patients awaiting kidney transplantation
- •BMI <18 and >30 kg/m2
- •Malnourished patients with albumin levels less than 3 g/dL who need additional supplementation of calories and nutrients
- •Severe liver disease, malignant disease, infectious disease
- •Existing gastrointestinal diseases or pathological findings, which do not allow EN, e.g. intestinal atony, ileus, acute upper GI bleeding, shock, or malabsorption, e.g. inflammatory bowel disease, pancreatic disease, or previous surgical GI resection
- •Severely impaired gastrointestinal function, i.e. severe constipation or acute diarrhea (≥ 3 loose or watery stools per day)
- •Dysphagia or high aspiration risk
- •Relevant CNS and/or psychiatric disorders
- •Known allergic reaction or intolerance to any of the ingredients of the study product
- •Planned surgery or hospitalization during study period
- •Suspicion of drug abuse
- •Patients unable to follow study instructions or keeping a dietary diary
- •Pregnant or lactating women
- •Participation in another clinical trial with an investigational product within 30 days prior to start of study or during the study
研究组 & 干预措施
Intervention group
Experimental
Low protein diet with Fresubin® renal
干预措施: Low protein diet with Fresubin® renal (Dietary Supplement)
Standard of care
Other
Low protein diet with normal food
干预措施: Low protein diet with normal food (Other)
结局指标
主要结局
Change of body weight
时间窗: baseline to week 4
Body weight measured in kilograms
次要结局
- Change body composition(baseline to week 4)
- Change of CRP(baseline to week 4)
- Change of waist circumference levels(baseline to week 4)
- Change of electrolytes(baseline to week 4)
- Safety and compliance.(baseline to week 4)
- Change 3-day dietary record(baseline to week 4)
- Change of renal fuction(baseline to week 4)
- Change in lipid analysis(baseline to week 4)
- Change of Body Mass Index (BMI) levels(baseline to week 4)
- Change of grip strength levels(baseline to week 4)
- Change of nutrition status in blood test(baseline to week 4)
- Change of daily protein intake(baseline to week 4)
研究者
研究点 (1)
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