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

NCT06568991 | Completed

• 1 other identifier: KMUHIRB-F(II)-20150030
• Study Type: interventional
• Target: 127
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 2.To assess nutritional status improved or maintained after low protein rice intervention.
3. 3.To assess whether the patient's renal function improved or maintained after low protein rice intervention.

Conditions

Chronic Kidney Disease (CKD)

Keywords

low protein; chronic kidney disease; nutritional

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• Body weight (kg)

  baseline, 6 month

• muscle mass (kg)

  baseline, 6 month

• fat mass (%)

  baseline, 6 month

• energy intake (Kcal/day)

  baseline, 6 month

• protein intake (g/day)

  baseline, 6 month

Study Arms (2)

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

Dietary Supplement: Low Protein Rice MATSUBUMAI

the True Low Protein Rice group

ACTIVE COMPARATOR

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

Dietary Supplement: Low Protein Rice MATSUBUMAI

Interventions

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.

Observational control group; the True Low Protein Rice group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• were undergoing dialysis
• had cancer under any treatmen
• had any major surgery before or after the study period
• were pregnant or breastfeeding
• were diagnosed with alcoholism
• had liver, gastrointestinal tract, or other metabolic diseases
• and/or had been determined by a physician to be clinically unstable.
• Subject is participating in another study that has not been approved as a concomitant study by Low Protein Rice.
• Subjects consuming oral nutritional supplement(ONS) \>3 times/week for the control group and subjects consuming any ONS for the low protein rice group.
• Patients were diagnosed with stages 3b-5 CKD with an estimated glomerular filtration rate (eGFR) of 15-44 mL/min/1.73 m2.
• Patients were aged 30-70 years
• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: August 23, 2024
• Study Start: May 26, 2015
• Primary Completion: January 11, 2019
• Study Completion: January 11, 2019
• Last Updated: August 23, 2024

Record last verified: 2024-08