NCT06560541

Rice Intervention in Chronic Health Study

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Taylor's University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
OTHER	UKMRC9	UKMRC9 is a low glycemic index and polyphenol-rich red pigmented rice
OTHER	White rice	White rice refers to a local polished rice

Timeline

• Start date: 2021-05-28
• Primary completion: 2024-05-28
• Completion: 2024-08-12
• First posted: 2024-08-19
• Last updated: 2024-08-26

Locations

10 sites across 1 country: Malaysia