Diabetes Mellitus, Type 2
Conditions
Keywords
Pigmented rice, Whole grain rice, Type 2 diabetes, Cardio-metabolic health, Mitochondrial DNA methylation, Circulating exosomal miRNA, Metabolomics, Consumer acceptance test
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.
Interventions
OTHERUKMRC9
UKMRC9 is a low glycemic index and polyphenol-rich red pigmented rice
OTHERWhite rice
White rice refers to a local polished rice
Sponsors
National University of Malaysia
Universiti Putra Malaysia
National Institutes of Health, Ministry of Health Malaysia
University of Nottingham Malaysia
Taylor's University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Although the participants will not be blinded to the investigator product (IP), they will be masked from the brand of the IP.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Diabetes Arm: Inclusion Criteria: * Attending outpatient clinics * Age 18 - 60 years (i.e. adult population) * Both male and female * Regular consumption of polished white rice (presumably high-GI) ≥ 200g/day * Established T2DM patients on oral medication * Glycated hemoglobin (HbA1c) 7% to 10% * Willing to take part and being compliant to the study protocol
Exclusion criteria
* Glycated hemoglobin (HbA1c) \<7% or \>10% * Use of insulin * A change in the type of treatment (e.g. insulin injection) during the intervention period * Regular consumption of low-GI rice types (basmati) or colored rice (red rice, purple rice, black rice) for ≥3 months. * Oral corticosteroids \> 3 months * Pregnancy * Unstable medical condition. * Undergone any major operation in the past 3 months * Chronic alcohol drinker. * Not on weight loss diets or supplementation. * Taking part in another clinical trial. Healthy arm: Inclusion Criteria: * Healthy free living * With glycated haemoglobin (HbA1c \<6.3%) * Age 18 - 60 years (i.e. adult population) * Both male and female * Regular consumption of polished white rice (presumably high-GI) ≥ 200g/day * Generally, physically and mentally healthy as per medical examination. * Willing to take part and being compliant to the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in cardio-metabolic parameters | Baseline versus 12-week versus 24-week | 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 |
| Changes in urinary and plasma metabolome | Baseline versus 12-week versus 24-week | Effects of UKMRC9 on urinary and plasma metabolome |
| Changes in mitochondrial DNA methylation and circulating miRNAs expression | Baseline versus 24-week | Effects of UKMRC9 on mitochondrial DNA methylation and circulating miRNAs expression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diet Quality of Malaysian Adults with and without diabetes | Baseline screening | Diet quality will be benchmarked using the Healthy Eating Index (ranging from 0 to 100%), where a higher index indicates better diet quality. |
| Consumer Acceptance Test | Baseline versus 12-week versus 24-week | Difference in consumer acceptance between UKMRC9 and white rice |
| Changes in Advanced Glycation End (AGEs) products measured by skin autofluorescence using AGE Reader mu (Diagnostics). | Baseline versus 12-week versus 24-week | 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) |
| Facilitators and Barriers to the Inclusion of UKMRC9 as a staple food | 24-week | Participants' experience of substituting white rice with UKMRC9 explored through the focus group discussions. |
| Dietary Pattern of Malaysian Adults with and without diabetes | Baseline screening | 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. |
Countries
Malaysia
Outcome results
None listed