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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.
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.
Age
30 - 70 years
Sex
ALL
Healthy Volunteers
No
Start Date
May 26, 2015
Primary Completion Date
January 11, 2019
Completion Date
January 11, 2019
Last Updated
August 23, 2024
127
ACTUAL participants
Low Protein Rice MATSUBUMAI
DIETARY_SUPPLEMENT
Lead Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators
NCT04064827
NCT02119845
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07098078