Rice Intervention in Chronic Health Study
NCT Number: NCT06560541
Acronym: RICH
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus, Type 2
Interventions: OTHER: UKMRC9|OTHER: White rice
Sponsor: Taylor's University
Collaborators: National University of Malaysia|Universiti Putra Malaysia|National Institutes of Health, Ministry of Health Malaysia|University of Nottingham Malaysia
Sex: ALL
Age: ADULT
Enrollment: 204
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-05-28
Completion Date: 2024-08-12
Locations: Hospital Canselor Tuanku Muhriz, Cheras, Kuala Lumpur, 56000, Malaysia|Klinik Kesihatan Cheras, Cheras, Kuala Lumpur, 56000, Malaysia|Klinik Kesihatan Bandar Baru Bangi, Bangi, Selangor, 43650, Malaysia|Klinik Kesihatan Kajang, Kajang, Selangor, 43000, Malaysia|Klinik Kesihatan Sungai Chua, Kajang, Selangor, 43000, Malaysia|The University of Nottingham Malaysia Compus, Semenyih, Selangor, 43500, Malaysia|Hospital Pengajar Universiti Putra Malaysia, Seri Kembangan, Selangor, 43400, Malaysia|Universiti Putra Malaysia, Seri Kembangan, Selangor, 43400, Malaysia|Institute for Medical Research, Shah Alam, Selangor, 40170, Malaysia|Taylor's University, Subang Jaya, Selangor, 47500, Malaysia

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.

Primary Outcome Measures: 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, Baseline versus 12-week versus 24-week|Changes in urinary and plasma metabolome, Effects of UKMRC9 on urinary and plasma metabolome, 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, Baseline versus 24-week
Secondary Outcome Measures: Consumer Acceptance Test, Difference in consumer acceptance between UKMRC9 and white rice, 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., 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., 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., 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), Baseline versus 12-week versus 24-week