A high energy and low protein renal formula tailored for the specific needs of pre-dialysis CKD patients.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
84
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.
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.
Taichung Verterans General Hospital Taichung
Taichung, ROC, Taiwan
Change of body weight
Body weight measured in kilograms
Time frame: baseline to week 4
Change 3-day dietary record
Total energy intake,3 macronutrients (carbohydrates, protein and lipids) and micronutrients
Time frame: baseline to week 4
Change body composition
Body composition measured by bioelectrical impedance analyses
Time frame: baseline to week 4
Change of renal fuction
blood urea nitrogen,serum creatinine and estimated glomerular filtration rate
Time frame: baseline to week 4
Change of electrolytes
Sodium,potassium,calciam,phosphorus and magnesium in the blood
Time frame: baseline to week 4
Safety and compliance.
gastrointestinal symptoms measured by questionnaire
Time frame: baseline to week 4
Change in lipid analysis
Change of cholesterol ,triglyceride ,and LDL-cholesterol in the blood
Time frame: baseline to week 4
Change of Body Mass Index (BMI) levels
BMI was calculate by body weight (kg) divided by the square of the height (m\^2)
Time frame: baseline to week 4
Change of waist circumference levels
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Waist circumference was measured by a tape
Time frame: baseline to week 4
Change of grip strength levels
hand grip strength was measured by grip strength device
Time frame: baseline to week 4
Change of CRP
Change of CRP in the blood
Time frame: baseline to week 4
Change of nutrition status in blood test
Serum albumin, pre-albumin, total protein, uric acid
Time frame: baseline to week 4
Change of daily protein intake
24-hour urine estimated protein intake with Maroni formula
Time frame: baseline to week 4