Chronic Kidney Disease
Conditions
Keywords
Chronic kidney disease, Oral nutrition supplement
Brief summary
A high energy and low protein renal formula tailored for the specific needs of pre-dialysis CKD patients.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTLow protein diet with Fresubin® renal
Low protein diet with Fresubin® renal Dosage: 1 bottle per day as a replacement for one regular meal. All patients will get individualized dietary counseling aimed at achieving a protein intake of 0.6-0.8 g/kg actual body weight/day and an energy intake of 30-35 kcal/kg actual body weight.
OTHERLow protein diet with normal food
All patients will get individualized dietary counseling aimed at achieving a protein intake of 0.6-0.8 g/kg actual body weight/day and an energy intake of 30-35 kcal/kg actual body weight/day.
Sponsors
Fresenius Kabi Taiwan Ltd.
Taichung Veterans General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of body weight | baseline to week 4 | Body weight measured in kilograms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and compliance. | baseline to week 4 | gastrointestinal symptoms measured by questionnaire |
| Change of grip strength levels | baseline to week 4 | hand grip strength was measured by grip strength device |
| Change of CRP | baseline to week 4 | Change of CRP in the blood |
| Change in lipid analysis | baseline to week 4 | Change of cholesterol ,triglyceride ,and LDL-cholesterol in the blood |
| Change of Body Mass Index (BMI) levels | baseline to week 4 | BMI was calculate by body weight (kg) divided by the square of the height (m\^2) |
| Change of electrolytes | baseline to week 4 | Sodium,potassium,calciam,phosphorus and magnesium in the blood |
| Change body composition | baseline to week 4 | Body composition measured by bioelectrical impedance analyses |
| Change of renal fuction | baseline to week 4 | blood urea nitrogen,serum creatinine and estimated glomerular filtration rate |
| Change 3-day dietary record | baseline to week 4 | Total energy intake,3 macronutrients (carbohydrates, protein and lipids) and micronutrients |
| Change of nutrition status in blood test | baseline to week 4 | Serum albumin, pre-albumin, total protein, uric acid |
| Change of daily protein intake | baseline to week 4 | 24-hour urine estimated protein intake with Maroni formula |
| Change of waist circumference levels | baseline to week 4 | Waist circumference was measured by a tape |
Countries
Taiwan
Outcome results
None listed