Chronic Kidney Disease Clinical Trial
Official title:
Effect of Low-protein Formula Nutritional Supplements on Renal Function Progression, Muscle Mass and Physical Activity With Chronic Kidney Disease
Verified date | March 2022 |
Source | Taichung Veterans General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 95 |
Est. completion date | December 31, 2021 |
Est. primary completion date | October 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Taichung Verterans General Hospital Taichung | Taichung |
Lead Sponsor | Collaborator |
---|---|
Taichung Veterans General Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of muscle strength | Hand grip strength | Baseline to 12 weeks and 24 weeks | |
Primary | Change of Gait speed | Gait speed measurement | Baseline to 12 weeks and 24 weeks | |
Primary | Change of 5-meter distance walk | 5-meter distance walk measurement | Baseline to 12 weeks and 24 weeks | |
Primary | Change of nutrition status | Mini Nutritional Assessment Short-Form score | Baseline to 12 weeks and 24 weeks | |
Primary | Change of body composition | Using bioelectrical impedance analysis(BIA, Tanita MC-780, Japan) | Baseline to 12 weeks and 24 weeks | |
Primary | Change of total energy intake | 24-hour dietary record measurement | Baseline to 12 weeks and 24 weeks | |
Primary | Change of protein intake | 24-hour dietary record measurement | Baseline to 12 weeks and 24 weeks | |
Primary | Change of carbohydrate intake | 24-hour dietary record measurement | Baseline to 12 weeks and 24 weeks | |
Primary | Change of fat intake | 24-hour dietary record measurement | Baseline to 12 weeks and 24 weeks | |
Primary | Change of micronutrients intake | 24-hour dietary record measurement | Baseline to 12 weeks and 24 weeks | |
Secondary | Change of serum creatinine | renal function monitoring | Baseline to 12 weeks and 24 weeks | |
Secondary | Change of blood urea nitrogen | renal function monitoring | Baseline to 12 weeks and 24 weeks | |
Secondary | Change of estimated glomerular filtration rate | renal function monitoring | Baseline to 12 weeks and 24 weeks | |
Secondary | Change of daily protein intake. | 24-hour urine estimated protein intake with Maroni formula | Baseline to 12 weeks and 24 weeks | |
Secondary | Change of albumin | Change of albumin in the blood | Baseline to 12 weeks and 24 weeks | |
Secondary | Change of sodium | electrolyte measurement in the blood | Baseline to 12 weeks and 24 weeks | |
Secondary | Change of potassium | electrolyte measurement in the blood | Baseline to 12 weeks and 24 weeks | |
Secondary | Change of calcium | electrolyte measurement in the blood | Baseline to 12 weeks and 24 weeks | |
Secondary | Change of phosphorus | electrolyte measurement in the blood | Baseline to 12 weeks and 24 weeks | |
Secondary | Change of magnesium | electrolyte measurement in the blood | Baseline to 12 weeks and 24 weeks | |
Secondary | Change of Hemoglobin A1c | monitoring and diagnosis diabetes | Baseline to 12 weeks and 24 weeks | |
Secondary | Change of blood sugar | Blood sugar testing | Baseline to 12 weeks and 24 weeks | |
Secondary | Change of CRP | Change of CRP in the blood | Baseline to 12 weeks and 24 weeks | |
Secondary | Change of red blood cell | Routine Blood Tests in the blood | Baseline to 12 weeks and 24 weeks | |
Secondary | Change of White blood cell | Routine Blood Tests in the blood | Baseline to 12 weeks and 24 weeks | |
Secondary | Change of hemoglobin | Routine Blood Tests in the blood | Baseline to 12 weeks and 24 weeks | |
Secondary | Change of hematocrit | Routine Blood Tests in the blood | Baseline to 12 weeks and 24 weeks | |
Secondary | Change of liver function | Change of ALT and AST in the blood | Baseline to 12 weeks and 24 weeks | |
Secondary | Change of cholesterol | Change in lipid analysis in the blood | Baseline to 12 weeks and 24 weeks | |
Secondary | Change of triglyceride | Change in lipid analysis in the blood | Baseline to 12 weeks and 24 weeks | |
Secondary | Change of LDL-cholesterol | Change in lipid analysis in the blood | Baseline to 12 weeks and 24 weeks |
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