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| Name | Class |
|---|---|
| TAIWAN KITOKU CO., LTD. | UNKNOWN |
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Recruited the subjects procedures A physical checking the history and blood biochemical data will be carried out by the study physician to verify eligibility for enrollment study at outpatient. A physical explain and answer about the study procedure and criteria to subjects.
Subjects review informed consent and sign it.
The trail procedures(brief describe)
1.After the subjects will sign informed consent form at the outpatient, they will be enrolled (phone) and schedule study visit1 (M0) by study staff. 2.The study visit1 will collect demographics, blood, urine and distribute product and product consumption diaries, and perform SGA (Subjective Global Assessment). 3.The study visit2 (M1), after the product be used for 4 weeks, will collect adverse event, blood,urine, and SGA. 4.The study visit3(M3), after the product be used for 12 weeks, will collect adverse event, blood,urine, and SGA. 5.The study visit4(M6), after the product be used for 24 weeks, will collect adverse event, blood,urine, and SGA. 3.Subject and study design: Investigators will recruit 100 subjects participating in the"PRE-ESRD education plan" at KMUH.
Subjects will receive dietary education of low protein diet (providing energy 25 to 35 Kcal/Kg/day, protein 0.6 to 0.8 g/Kg/day) by dietitians. Subjects will be randomly assigned to a observational group or rue low protein rice group. Observational group (n=40): Forty subjects will be enrolled. Subjects will receive routine dietary education of low protein diet. True Low Protein Rice group (n=60): Subjects will replace regular staple foods with low protein rice. Subjects will replace regular staple foods with low protein rice at levels of 40-160grams/ day. According to subjects' intake, subjects will be further divided into low & high intake groups for analysis. High intake group: Subjects consuming low Protein Rice at levels of 81-160 grams/day. Low intake group: Subjects consuming low Protein Rice at levels of 40-80 grams/day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational control group | Placebo Comparator | Giving a meal plan and nutrition education. It need to define recruited subject intake low-protein formula's frequency ≦ 3 times/week |
|
| the True Low Protein Rice group | Active Comparator | Use low protein rice to replace staple food in two meals during a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Protein Rice MATSUBUMAI | Dietary Supplement | Investigators will recruit 100 subjects participating in the"PRE-ESRD education plan" at KMUH. Subjects will receive dietary education of low protein diet (providing energy 25 to 35 Kcal/Kg/day, protein 0.6 to 0.8 g/Kg/day) by dietitians. Subjects will be randomly assigned to a observational group or rue low protein rice group. |
| Measure | Description | Time Frame |
|---|---|---|
| albumin (g/dL) | nutritional indicators | baseline, 6 month |
| nitrogen balance (g/day) | nutritional indicators | baseline, 6 month |
| handgrip strength (kg) | nutritional indicators | baseline, 6 month |
| blood urea nitrogen (mg/dL) | residual renal function | baseline, 6 month |
| creatinine (mg/dL) | residual renal function | baseline, 6 month |
| estimated glomerular filtration rate (eGFR) (mL/min/1.73m2) | residual renal function | baseline, 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight (kg) | Body composition | baseline, 6 month |
| muscle mass (kg) | Body composition | baseline, 6 month |
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Exclusion criterias
Inclusion criteria
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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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|
| fat mass (%) | Body composition | baseline, 6 month |
| energy intake (Kcal/day) | Nutrient intakes | baseline, 6 month |
| protein intake (g/day) | Nutrient intakes | baseline, 6 month |
| potassium (mmol/L) | electrolytes | baseline, 6 month |
| phosphorus (mg/dL) | electrolytes | baseline, 6 month |
| 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 |