Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568991
Status:
COMPLETED
Last Update Posted:
None
First Post:
2022-02-09
Brief Title:
The Effect of Low-protein Rice on Nutritional Status and Other Outcomes of Patients With Chronic Kidney DiseaseKS01
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Low-protein Rice on Nutritional Status and Other Outcomes of Patients With Chronic Kidney Disease
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 0136 month
2 To assess nutritional status improved or maintained after low protein rice intervention
3 To assess whether the patients renal function improved or maintained after low protein rice intervention
2 To assess nutritional status improved or maintained after low protein rice intervention
3 To assess whether the patients 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 proceduresbrief describe
1After the subjects will sign informed consent form at the outpatient they will be enrolled phone and schedule study visit1 M0 by study staff 2The study visit1 will collect demographics blood urine and distribute product and product consumption diaries and perform SGA Subjective Global Assessment 3The study visit2 M1 after the product be used for 4 weeks will collect adverse event bloodurine and SGA 4The study visit3M3 after the product be used for 12 weeks will collect adverse event bloodurine and SGA 5The study visit4M6 after the product be used for 24 weeks will collect adverse event bloodurine and SGA 3Subject and study design Investigators will recruit 100 subjects participating in thePRE-ESRD education plan at KMUH
Subjects will receive dietary education of low protein diet providing energy 25 to 35 KcalKgday protein 06 to 08 gKgday by dietitians Subjects will be randomly assigned to a observational group or rue low protein rice group Observational group n40 Forty subjects will be enrolled Subjects will receive routine dietary education of low protein diet True Low Protein Rice group n60 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 gramsday Low intake group Subjects consuming low Protein Rice at levels of 40-80 gramsday
Subjects review informed consent and sign it
2 The trail proceduresbrief describe
1After the subjects will sign informed consent form at the outpatient they will be enrolled phone and schedule study visit1 M0 by study staff 2The study visit1 will collect demographics blood urine and distribute product and product consumption diaries and perform SGA Subjective Global Assessment 3The study visit2 M1 after the product be used for 4 weeks will collect adverse event bloodurine and SGA 4The study visit3M3 after the product be used for 12 weeks will collect adverse event bloodurine and SGA 5The study visit4M6 after the product be used for 24 weeks will collect adverse event bloodurine and SGA 3Subject and study design Investigators will recruit 100 subjects participating in thePRE-ESRD education plan at KMUH
Subjects will receive dietary education of low protein diet providing energy 25 to 35 KcalKgday protein 06 to 08 gKgday by dietitians Subjects will be randomly assigned to a observational group or rue low protein rice group Observational group n40 Forty subjects will be enrolled Subjects will receive routine dietary education of low protein diet True Low Protein Rice group n60 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 gramsday Low intake group Subjects consuming low Protein Rice at levels of 40-80 gramsday
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None