The Effect of Low-protein Rice on Nutritional Status and Other Outcomes of Patients With Chronic Kidney Disease.(KS01)

The Effect of Low-protein Rice on Nutritional Status and Other Outcomes of Patients With Chronic Kidney Disease.

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease (CKD)
• Intervention / Treatment: Dietary supplement: Low Protein Rice MATSUBUMAI

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.

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Exclusion criterias

1. were undergoing dialysis
2. had cancer under any treatmen
3. had any major surgery before or after the study period
4. were pregnant or breastfeeding
5. were diagnosed with alcoholism
6. had liver, gastrointestinal tract, or other metabolic diseases
7. and/or had been determined by a physician to be clinically unstable.
8. Subject is participating in another study that has not been approved as a concomitant study by Low Protein Rice.
9. Subjects consuming oral nutritional supplement(ONS) >3 times/week for the control group and subjects consuming any ONS for the low protein rice group.

Inclusion criteria

1. Patients were diagnosed with stages 3b-5 CKD with an estimated glomerular filtration rate (eGFR) of 15-44 mL/min/1.73 m2.
2. Patients were aged 30-70 years
3. Patients received pre-end-stage renal disease (pre-ESRD) care under a pay-for-performance program (P4P) at the Department of Nephrology at Kaohsiung Medical University Hospital.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Observational control group; Giving a meal plan and nutrition education. It need to define recruited subject intake low-protein formula's frequency ≦ 3 times/week	Dietary supplement: Low Protein Rice MATSUBUMAI; 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.
Active Comparator: the True Low Protein Rice group; Use low protein rice to replace staple food in two meals during a day.	Dietary supplement: Low Protein Rice MATSUBUMAI; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight (kg)	Body composition	baseline, 6 month
muscle mass (kg)	Body composition	baseline, 6 month
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

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Collaborators: TAIWAN KITOKU CO., LTD.

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2015
• Primary Completion (Actual): January 11, 2019
• Study Completion (Actual): January 11, 2019

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: chronic kidney disease; nutritional; low protein
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: KMUHIRB-F(II)-20150030