Low-protein Formula Supplements in Chronic Kidney Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Low-protein Formula Nutritional Supplements on Renal Function Progression, Muscle Mass and Physical Activity With Chronic Kidney Disease

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Dietary Supplement: Intervention group
* Other: Regular nutrition education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is >65years of age. Subject has been diagnosed with Chronic Kidney Disease (CKD) and is classified as being between Stages 3 to 5. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Regular nutrition education and supply one serving per day of 6% low protein formula. | Dietary Supplement: Intervention group<br>* 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<br>|
| Placebo Comparator: Regular nutrition education<br>Regular nutrition education | Other: Regular nutrition education<br>* dietitian regular nutrition educataion which was following a low protein diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of muscle strength | Hand grip strength | Baseline to 12 weeks and 24 weeks | 
| Change of Gait speed | Gait speed measurement | Baseline to 12 weeks and 24 weeks | 
| Change of 5-meter distance walk | 5-meter distance walk measurement | Baseline to 12 weeks and 24 weeks | 
| Change of nutrition status | Mini Nutritional Assessment Short-Form score | Baseline to 12 weeks and 24 weeks | 
| Change of body composition | Using bioelectrical impedance analysis(BIA, Tanita MC-780, Japan) | Baseline to 12 weeks and 24 weeks | 
| Change of total energy intake | 24-hour dietary record measurement | Baseline to 12 weeks and 24 weeks | 
| Change of protein intake | 24-hour dietary record measurement | Baseline to 12 weeks and 24 weeks | 
| Change of carbohydrate intake | 24-hour dietary record measurement | Baseline to 12 weeks and 24 weeks | 
| Change of fat intake | 24-hour dietary record measurement | Baseline to 12 weeks and 24 weeks | 
| Change of micronutrients intake | 24-hour dietary record measurement | Baseline to 12 weeks and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of serum creatinine | renal function monitoring | Baseline to 12 weeks and 24 weeks | 
| Change of blood urea nitrogen | renal function monitoring | Baseline to 12 weeks and 24 weeks | 
| Change of estimated glomerular filtration rate | renal function monitoring | Baseline to 12 weeks and 24 weeks | 
| Change of daily protein intake. | 24-hour urine estimated protein intake with Maroni formula | Baseline to 12 weeks and 24 weeks | 
| Change of albumin | Change of albumin in the blood | Baseline to 12 weeks and 24 weeks | 
| Change of sodium | electrolyte measurement in the blood | Baseline to 12 weeks and 24 weeks | 
| Change of potassium | electrolyte measurement in the blood | Baseline to 12 weeks and 24 weeks | 
| Change of calcium | electrolyte measurement in the blood | Baseline to 12 weeks and 24 weeks | 
| Change of phosphorus | electrolyte measurement in the blood | Baseline to 12 weeks and 24 weeks | 
| Change of magnesium | electrolyte measurement in the blood | Baseline to 12 weeks and 24 weeks | 
| Change of Hemoglobin A1c | monitoring and diagnosis diabetes | Baseline to 12 weeks and 24 weeks | 
| Change of blood sugar | Blood sugar testing | Baseline to 12 weeks and 24 weeks | 
| Change of CRP | Change of CRP in the blood | Baseline to 12 weeks and 24 weeks | 
| Change of red blood cell | Routine Blood Tests in the blood | Baseline to 12 weeks and 24 weeks | 
| Change of White blood cell | Routine Blood Tests in the blood | Baseline to 12 weeks and 24 weeks | 
| Change of hemoglobin | Routine Blood Tests in the blood | Baseline to 12 weeks and 24 weeks | 
| Change of hematocrit | Routine Blood Tests in the blood | Baseline to 12 weeks and 24 weeks | 
| Change of liver function | Change of ALT and AST in the blood | Baseline to 12 weeks and 24 weeks | 
| Change of cholesterol | Change in lipid analysis in the blood | Baseline to 12 weeks and 24 weeks | 
| Change of triglyceride | Change in lipid analysis in the blood | Baseline to 12 weeks and 24 weeks | 
| Change of LDL-cholesterol | Change in lipid analysis in the blood | Baseline to 12 weeks and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral nutrition supplement, Chronic kidney disease