The Effect of Low-protein Rice on Nutritional Status and Other Outcomes of Patients With Chronic Kidney Disease.(KS01)
- Conditions
- Chronic Kidney Disease (CKD)
- Interventions
- Dietary Supplement: Low Protein Rice MATSUBUMAI
- Registration Number
- NCT06568991
- Brief Summary
1. To examine nutrient intake change in chronic kidney disease patients consuming " Low Protein Rice MATSUBUMAI "compared to a regular care group at 0,1,3,6 month.
2. To assess nutritional status improved or maintained after low protein rice intervention.
3. To assess whether the patient's renal function improved or maintained after low protein rice intervention.
- Detailed Description
1. 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.
2. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 127
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Observational control group Low Protein Rice MATSUBUMAI 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 Low Protein Rice MATSUBUMAI Use low protein rice to replace staple food in two meals during a day.
- Primary Outcome Measures
Name Time Method estimated glomerular filtration rate (eGFR) (mL/min/1.73m2) baseline, 6 month residual renal function
creatinine (mg/dL) baseline, 6 month residual renal function
albumin (g/dL) baseline, 6 month nutritional indicators
handgrip strength (kg) baseline, 6 month nutritional indicators
blood urea nitrogen (mg/dL) baseline, 6 month residual renal function
nitrogen balance (g/day) baseline, 6 month nutritional indicators
- Secondary Outcome Measures
Name Time Method protein intake (g/day) baseline, 6 month Nutrient intakes
fat mass (%) baseline, 6 month Body composition
potassium (mmol/L) baseline, 6 month electrolytes
phosphorus (mg/dL) baseline, 6 month electrolytes
Body weight (kg) baseline, 6 month Body composition
muscle mass (kg) baseline, 6 month Body composition
energy intake (Kcal/day) baseline, 6 month Nutrient intakes