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| Name | Class |
|---|---|
| Fresenius Kabi Taiwan Ltd. | INDUSTRY |
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A high energy and low protein renal formula tailored for the specific needs of pre-dialysis CKD patients.
Previous studies indicated that low-protein formula nutritional supplements may improve compliance with an LPD and are beneficial in the management of pre-dialysis CKD patients
This study will evaluate the suitability of the disease-specific enteral formula Fresubin® renal in predialysis chronic kidney disease patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Low protein diet with Fresubin® renal |
|
| Standard of care | Other | Low protein diet with normal food |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low protein diet with Fresubin® renal | Dietary Supplement | Low protein diet with Fresubin® renal Dosage: 1 bottle per day as a replacement for one regular meal. All patients will get individualized dietary counseling aimed at achieving a protein intake of 0.6-0.8 g/kg actual body weight/day and an energy intake of 30-35 kcal/kg actual body weight. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of body weight | Body weight measured in kilograms | baseline to week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change 3-day dietary record | Total energy intake,3 macronutrients (carbohydrates, protein and lipids) and micronutrients | baseline to week 4 |
| Change body composition | Body composition measured by bioelectrical impedance analyses |
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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 | ROC | 40705 | Taiwan |
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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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| ID | Term |
|---|---|
| D018753 | Diet, Protein-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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|
| Low protein diet with normal food | Other | All patients will get individualized dietary counseling aimed at achieving a protein intake of 0.6-0.8 g/kg actual body weight/day and an energy intake of 30-35 kcal/kg actual body weight/day. |
|
| baseline to week 4 |
| Change of renal fuction | blood urea nitrogen,serum creatinine and estimated glomerular filtration rate | baseline to week 4 |
| Change of electrolytes | Sodium,potassium,calciam,phosphorus and magnesium in the blood | baseline to week 4 |
| Safety and compliance. | gastrointestinal symptoms measured by questionnaire | baseline to week 4 |
| Change in lipid analysis | Change of cholesterol ,triglyceride ,and LDL-cholesterol in the blood | baseline to week 4 |
| Change of Body Mass Index (BMI) levels | BMI was calculate by body weight (kg) divided by the square of the height (m^2) | baseline to week 4 |
| Change of waist circumference levels | Waist circumference was measured by a tape | baseline to week 4 |
| Change of grip strength levels | hand grip strength was measured by grip strength device | baseline to week 4 |
| Change of CRP | Change of CRP in the blood | baseline to week 4 |
| Change of nutrition status in blood test | Serum albumin, pre-albumin, total protein, uric acid | baseline to week 4 |
| Change of daily protein intake | 24-hour urine estimated protein intake with Maroni formula | baseline to week 4 |
| 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 |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |