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Purpose of study To evaluate suitability of two flavours of a high energy low protein formula (Renalive® LP) as oral nutritional supplement and meal replacement in chronic kidney disease stage 3b-5 outpatients Inclusion criteria (1) Diagnosed with chronic kidney disease stage 3b-5 (with history of eGFR<45 mL/min/1.73 m2) (2) Age: ≥18 years (3) Outpatients with instruction to keep a low protein diet (0.55-0.8 g protein /kg actual body weight/ day) in the last 3 months as evaluated by the Investigator.
(4) Written Informed Consent from patient. Exclusion criteria
Primary Endpoint
(1) Change in body weight from Baseline to end of treatment at Week 4 (Week 4 - Baseline) Secondary Endpoints
Daily dietary intake of energy, protein, sodium, potassium, magnesium, phosphorus, and calcium at Baseline, Week 2 and 4 based on a 3-Day Dietary Record
Change of nutritional status using body weight, BMI, and body composition as indicators:
Change of the physical performance using hand grip strength as an indicator from Baseline to Week 4
Change of renal function:
Serum albumin and pre-albumin at Baseline and Week 4
Blood electrolytes (sodium, potassium, phosphorus, calcium, magnesium) at Baseline, Week 2 and 4
Serum C-reactive protein (CRP) at Baseline, Week 2 and 4
Compliance rate (%) to Renalive® LP
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renalive® LP | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renalive® LP, flavour Vanilla | Dietary Supplement | flavour Vanilla |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight from Baseline to end of treatment at Week 4 (Week 4 - Baseline) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Daily dietary intake of energy, protein, sodium, potassium, magnesium, phosphorus, and calcium at Baseline, Week 2 and 4 based on a 3-Day Dietary Record | 4 weeks | |
| Change in BMI from Baseline to Week 2 and Week 4 | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaosiung Chang Gung Memorial Hospital | Kaohsiung City | Taiwan | ||||
| Taipei TzuChi Hospital |
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| Renalive® LP, flavour Cappuccino |
| Dietary Supplement |
flavour Cappuccino |
|
| Change in body composition from Baseline to Week 4 using bioelectrical impedance assessment | 4 weeks |
| Change of the physical performance using hand grip strength as an indicator from Baseline to Week 4 | 4 weeks |
| Change in estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) from Baseline to Week 4 | 4 weeks |
| Change in blood urea nitrogen and serum creatinine from Baseline to Week 2 and 4 | 4 weeks |
| Serum albumin and pre-albumin at Baseline and Week 4 | 4 weeks |
| Blood electrolytes (sodium, potassium, phosphorus, calcium, magnesium) at Baseline, Week 2 and 4 | 4 weeks |
| Serum C-reactive protein (CRP) at Baseline, Week 2 and 4 | 4 weeks |
| Compliance rate (%) to Renalive® LP | 4 weeks |
| New Taipei City |
| Taiwan |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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