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

NCT ID: NCT06568991

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-26
• Study Completion Date: 2019-01-11

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.

Conditions

Chronic Kidney Disease (CKD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: PLACEBO_COMPARATOR

Low Protein Rice MATSUBUMAI

Intervention Type: 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.

the True Low Protein Rice group

Use low protein rice to replace staple food in two meals during a day.

Group Type: ACTIVE_COMPARATOR

Low Protein Rice MATSUBUMAI

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TAIWAN KITOKU CO., LTD.

UNKNOWN

Sponsor Role: collaborator

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shang-Jyh,Hwang

Associate Dean

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

KMUHIRB-F(II)-20150030

Identifier Type: -

Identifier Source: org_study_id