Rice Intervention in Chronic Health Study

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

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

Sponsors & Collaborators

• National University of Malaysia

  collaborator OTHER

• Universiti Putra Malaysia

  collaborator OTHER

• National Institutes of Health, Ministry of Health Malaysia

  collaborator OTHER

• University of Nottingham Malaysia

  collaborator OTHER

• Taylor's University

  lead OTHER

Principal Investigators

• Tilakavati Karupaiah, PhD · Taylor's University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-05-28

Primary Completion

2024-05-28

Completion

2024-08-12

Countries

• Malaysia

Study Locations