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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
204
UKMRC9 is a low glycemic index and polyphenol-rich red pigmented rice
White rice refers to a local polished rice
Hospital Canselor Tuanku Muhriz
Cheras, Kuala Lumpur, Malaysia
Klinik Kesihatan Cheras
Cheras, Kuala Lumpur, Malaysia
Klinik Kesihatan Bandar Baru Bangi
Bangi, Selangor, Malaysia
Klinik Kesihatan Kajang
Kajang, Selangor, Malaysia
Klinik Kesihatan Sungai Chua
Kajang, Selangor, Malaysia
The University of Nottingham Malaysia Compus
Semenyih, Selangor, Malaysia
Hospital Pengajar Universiti Putra Malaysia
Seri Kembangan, Selangor, Malaysia
Universiti Putra Malaysia
Seri Kembangan, Selangor, Malaysia
Institute for Medical Research
Shah Alam, Selangor, Malaysia
Taylor's University
Subang Jaya, Selangor, Malaysia
Changes in cardio-metabolic parameters
Effects of 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
Time frame: Baseline versus 12-week versus 24-week
Changes in urinary and plasma metabolome
Effects of UKMRC9 on urinary and plasma metabolome
Time frame: Baseline versus 12-week versus 24-week
Changes in mitochondrial DNA methylation and circulating miRNAs expression
Effects of UKMRC9 on mitochondrial DNA methylation and circulating miRNAs expression
Time frame: Baseline versus 24-week
Consumer Acceptance Test
Difference in consumer acceptance between UKMRC9 and white rice
Time frame: Baseline versus 12-week versus 24-week
Facilitators and Barriers to the Inclusion of UKMRC9 as a staple food
Participants' experience of substituting white rice with UKMRC9 explored through the focus group discussions.
Time frame: 24-week
Dietary Pattern of Malaysian Adults with and without diabetes
The dietary pattern will be assessed at baseline using two distinct methods to provide a comprehensive evaluation of dietary intakes: (1) 3-day diet record, which will capture short-term food intakes and (2) food frequency questionnaire, which assess habitual, long term dietary intakes. The dietary data from each method will be reported in gram per day (g/d) and analysed separately using dimension reduction techniques to produce unified dietary pattern scores. This score will be categorized into tertiles (T1: 0-33.3%, T2: 33.4-66.7%, T3: 66.8-100%) for further analysis. Higher tertile indicates stronger adherence to the established dietary pattern.
Time frame: Baseline screening
Diet Quality of Malaysian Adults with and without diabetes
Diet quality will be benchmarked using the Healthy Eating Index (ranging from 0 to 100%), where a higher index indicates better diet quality.
Time frame: Baseline screening
Changes in Advanced Glycation End (AGEs) products measured by skin autofluorescence using AGE Reader mu (Diagnostics).
This outcome measure assesses the effects of UKMRC9 on the levels of advanced glycation end products (AGEs) as measured by skin autofluorescence, using the AGE Reader mu (Diagnostic). The results will be expressed in arbitrary units (AU)
Time frame: Baseline versus 12-week versus 24-week
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