Chronic Kidney Disease
Conditions
Keywords
Oral nutrition supplement, Chronic kidney disease
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTIntervention group
dietitian regular nutrition education which was following a low protein diet and supply one serving per day of 6 % low protein formula (200mL,2kcal/ml) for 24 weeks
OTHERRegular nutrition education
dietitian regular nutrition educataion which was following a low protein diet
Sponsors
Taichung Veterans General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is \>65years of age. 2. Subject has been diagnosed with Chronic Kidney Disease (CKD) and is classified as being between Stages 3 to 5.
Exclusion criteria
1. The physician determines that the clinical condition is unstable. 2. Lower limb injury or severe edema. 3. food allergies to milk, or fish 4. There is a heart rhythm in the body and a prosthetic device. 5. Those who are unable to complete the questionnaire due to severe cognitive impairment as determined by the physician.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of muscle strength | Baseline to 12 weeks and 24 weeks | Hand grip strength |
| Change of Gait speed | Baseline to 12 weeks and 24 weeks | Gait speed measurement |
| Change of 5-meter distance walk | Baseline to 12 weeks and 24 weeks | 5-meter distance walk measurement |
| Change of nutrition status | Baseline to 12 weeks and 24 weeks | Mini Nutritional Assessment Short-Form score |
| Change of body composition | Baseline to 12 weeks and 24 weeks | Using bioelectrical impedance analysis(BIA, Tanita MC-780, Japan) |
| Change of total energy intake | Baseline to 12 weeks and 24 weeks | 24-hour dietary record measurement |
| Change of protein intake | Baseline to 12 weeks and 24 weeks | 24-hour dietary record measurement |
| Change of carbohydrate intake | Baseline to 12 weeks and 24 weeks | 24-hour dietary record measurement |
| Change of fat intake | Baseline to 12 weeks and 24 weeks | 24-hour dietary record measurement |
| Change of micronutrients intake | Baseline to 12 weeks and 24 weeks | 24-hour dietary record measurement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Hemoglobin A1c | Baseline to 12 weeks and 24 weeks | monitoring and diagnosis diabetes |
| Change of blood sugar | Baseline to 12 weeks and 24 weeks | Blood sugar testing |
| Change of CRP | Baseline to 12 weeks and 24 weeks | Change of CRP in the blood |
| Change of red blood cell | Baseline to 12 weeks and 24 weeks | Routine Blood Tests in the blood |
| Change of White blood cell | Baseline to 12 weeks and 24 weeks | Routine Blood Tests in the blood |
| Change of serum creatinine | Baseline to 12 weeks and 24 weeks | renal function monitoring |
| Change of hematocrit | Baseline to 12 weeks and 24 weeks | Routine Blood Tests in the blood |
| Change of liver function | Baseline to 12 weeks and 24 weeks | Change of ALT and AST in the blood |
| Change of cholesterol | Baseline to 12 weeks and 24 weeks | Change in lipid analysis in the blood |
| Change of triglyceride | Baseline to 12 weeks and 24 weeks | Change in lipid analysis in the blood |
| Change of LDL-cholesterol | Baseline to 12 weeks and 24 weeks | Change in lipid analysis in the blood |
| Change of hemoglobin | Baseline to 12 weeks and 24 weeks | Routine Blood Tests in the blood |
| Change of blood urea nitrogen | Baseline to 12 weeks and 24 weeks | renal function monitoring |
| Change of estimated glomerular filtration rate | Baseline to 12 weeks and 24 weeks | renal function monitoring |
| Change of daily protein intake. | Baseline to 12 weeks and 24 weeks | 24-hour urine estimated protein intake with Maroni formula |
| Change of albumin | Baseline to 12 weeks and 24 weeks | Change of albumin in the blood |
| Change of sodium | Baseline to 12 weeks and 24 weeks | electrolyte measurement in the blood |
| Change of potassium | Baseline to 12 weeks and 24 weeks | electrolyte measurement in the blood |
| Change of calcium | Baseline to 12 weeks and 24 weeks | electrolyte measurement in the blood |
| Change of phosphorus | Baseline to 12 weeks and 24 weeks | electrolyte measurement in the blood |
| Change of magnesium | Baseline to 12 weeks and 24 weeks | electrolyte measurement in the blood |
Countries
Taiwan
Outcome results
None listed