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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Regular nutrition education and supply one serving per day of 6% low protein formula. |
|
| Regular nutrition education | Placebo Comparator | Regular nutrition education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention group | Dietary Supplement | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheng-Hsu Chen, MDPHD | Division of Nephrology in Taichung Veterans General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taichung Verterans General Hospital Taichung | Taichung | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38097963 | Derived | Yang WC, Hsieh HM, Chen JP, Liu LC, Chen CH. Effects of a low-protein nutritional formula with dietary counseling in older adults with chronic kidney disease stages 3-5: a randomized controlled trial. BMC Nephrol. 2023 Dec 14;24(1):372. doi: 10.1186/s12882-023-03423-8. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Regular nutrition education | Other | dietitian regular nutrition educataion which was following a low protein diet |
|
| 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 |
| 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 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |