Rice Intervention in Chronic Health Study (RICH)

Taylor's University

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: UKMRC9; Other: White rice

Study type: Interventional

Funder types: Other

Identifiers

NCT06560541

RD0120Q1410

Details and patient eligibility

About

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.

Enrollment: 204 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 4 patient groups, including a placebo group

Diabetes Patients Cohort Red Rice (DPC-RR)

Experimental group

Treatment:

Other: UKMRC9

Diabetes Patients Cohort White Rice (DPC-WR)

Placebo Comparator group

Treatment:

Other: White rice

Healthy Control Cohort Red Rice (HCC-RR)

Experimental group

Treatment:

Other: UKMRC9

Healthy Control Cohort White Rice (HCC-WR)

Placebo Comparator group

Treatment:

Other: White rice