Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560541
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Rice Intervention in Chronic Health Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized and Open Label Phase 2 Clinical Trial of Low-GI Polyphenol-Rich UKMRC9 Red Rice on Cardiometabolic Parameters in Patients With Type 2 Diabetes
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:
RICH
Brief Summary:
The goal of this clinical trial is to learn if the low glycemic index GI polyphenol-rich red pigmented rice UKMRC9 works to improve cardio-metabolic parameters in Malaysian adults with type 2 diabetes T2D and healthy individuals It will also learn about the molecular and metabolic effects of UKMRC9 as well as its consumer acceptance The main questions it aims to answer are
1 What are the effects of substituting white rice with UKMRC9 on cardio-metabolic parameters including adiposity indices glycemic control lipid profiles appetite hormones total antioxidant capacity inflammatory markers blood pressure and 10-year cardiovascular risk in Malaysian adults T2D patients and healthy individuals
2 What are the effects of substituting white rice with UKMRC9 on urinary and plasma metabolome in Malaysian adults T2D patients and healthy individuals
3 What are the effects of substituting white rice with UKMRC9 on mitochondrial DNA methylation and circulating exosomal microRNAs expression in Malaysian adults T2D patients and healthy individuals
4 What is the difference in consumer acceptance toward UKMRC9 compared to white rice
5 What are the facilitators and barriers to the inclusion of UKMRC9 as a staple food in Malaysian diet
6 What are the dietary quality and dietary pattern among Malaysian adults T2D patients and healthy individuals
7 What is the effects of substituting white rice with UKMRC9 on advanced glycation end AGE products among Malaysian adults T2D patients and healthy individuals
Researchers will compare UKMRC9 to white rice to see if UKMRC9 works to improve cardio-metabolic parameters in Malaysian adults T2D patients and healthy individuals
Participants will
Take UKMRC9 or white rice everyday for 24 weeks
Visit the study sites once every 12 weeks for follow-up assessments
Share their experience in substituting white rice with UKMRC9 in focus group discussion at the end of the intervention
1 What are the effects of substituting white rice with UKMRC9 on cardio-metabolic parameters including adiposity indices glycemic control lipid profiles appetite hormones total antioxidant capacity inflammatory markers blood pressure and 10-year cardiovascular risk in Malaysian adults T2D patients and healthy individuals
2 What are the effects of substituting white rice with UKMRC9 on urinary and plasma metabolome in Malaysian adults T2D patients and healthy individuals
3 What are the effects of substituting white rice with UKMRC9 on mitochondrial DNA methylation and circulating exosomal microRNAs expression in Malaysian adults T2D patients and healthy individuals
4 What is the difference in consumer acceptance toward UKMRC9 compared to white rice
5 What are the facilitators and barriers to the inclusion of UKMRC9 as a staple food in Malaysian diet
6 What are the dietary quality and dietary pattern among Malaysian adults T2D patients and healthy individuals
7 What is the effects of substituting white rice with UKMRC9 on advanced glycation end AGE products among Malaysian adults T2D patients and healthy individuals
Researchers will compare UKMRC9 to white rice to see if UKMRC9 works to improve cardio-metabolic parameters in Malaysian adults T2D patients and healthy individuals
Participants will
Take UKMRC9 or white rice everyday for 24 weeks
Visit the study sites once every 12 weeks for follow-up assessments
Share their experience in substituting white rice with UKMRC9 in focus group discussion at the end of the intervention
Detailed Description:
None
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