CompletedNot Applicable

Rice Intervention in Chronic Health Study

Malaysia204 participantsStarted 2021-05-28

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. Exclusion Criteria: * Regular consumption of low-GI rice types (basmati) or colored rice (red rice, purple rice, black rice) for ≥3 months * Presence of gastrointestinal disease, metabolic diseases such as diabe…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in cardio-metabolic parameters

Timeframe: Baseline versus 12-week versus 24-week

Changes in urinary and plasma metabolome

Timeframe: Baseline versus 12-week versus 24-week

Changes in mitochondrial DNA methylation and circulating miRNAs expression

Timeframe: Baseline versus 24-week

Trial details

NCT IDNCT06560541

SponsorTaylor's University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-28

View on ClinicalTrials.gov More Diabetes Mellitus, Type 2 trials