Rice Intervention in Chronic Health Study
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Other: UKMRC9Other: White rice
- Registration Number
- NCT06560541
- Lead Sponsor
- Taylor's University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 204
- 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
- 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 diabetes, kidney failure, liver or pancreatic disease, hyperthyroidism, cancer or severe malnutrition.
- Oral corticosteroids > 3 months
- Pregnancy
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Healthy Control Cohort Red Rice (HCC-RR) UKMRC9 - Diabetes Patients Cohort Red Rice (DPC-RR) UKMRC9 - Diabetes Patients Cohort White Rice (DPC-WR) White rice - Healthy Control Cohort White Rice (HCC-WR) White rice -
- Primary Outcome Measures
Name Time Method 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
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
- Secondary Outcome Measures
Name Time Method Consumer Acceptance Test Baseline versus 12-week versus 24-week Difference in consumer acceptance between UKMRC9 and white rice
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.
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)
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.
Trial Locations
- Locations (10)
Klinik Kesihatan Sungai Chua
🇲🇾Kajang, Selangor, Malaysia
Institute for Medical Research
🇲🇾Shah Alam, Selangor, Malaysia
The University of Nottingham Malaysia Compus
🇲🇾Semenyih, Selangor, Malaysia
Klinik Kesihatan Bandar Baru Bangi
🇲🇾Bangi, Selangor, Malaysia
Universiti Putra Malaysia
🇲🇾Seri Kembangan, Selangor, Malaysia
Klinik Kesihatan Cheras
🇲🇾Cheras, Kuala Lumpur, Malaysia
Hospital Canselor Tuanku Muhriz
🇲🇾Cheras, Kuala Lumpur, Malaysia
Taylor's University
🇲🇾Subang Jaya, Selangor, Malaysia
Hospital Pengajar Universiti Putra Malaysia
🇲🇾Seri Kembangan, Selangor, Malaysia
Klinik Kesihatan Kajang
🇲🇾Kajang, Selangor, Malaysia