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Completed

NCT Number: NCT06560541

Rice Intervention in Chronic Health Study

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Canselor Tuanku Muhriz, Cheras, Kuala Lumpur, Malaysia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

UKMRC9

Other

UKMRC9 is a low glycemic index and polyphenol-rich red pigmented rice

White Rice

Other

White rice refers to a local polished rice

Primary outcomes

  1. Changes in cardio-metabolic parameters

    Time frame: 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

  2. Changes in urinary and plasma metabolome

    Time frame: Baseline versus 12-week versus 24-week

    Effects of UKMRC9 on urinary and plasma metabolome

  3. Changes in mitochondrial DNA methylation and circulating miRNAs expression

    Time frame: Baseline versus 24-week

    Effects of UKMRC9 on mitochondrial DNA methylation and circulating miRNAs expression

Secondary outcomes

  1. Consumer Acceptance Test

    Time frame: Baseline versus 12-week versus 24-week

    Difference in consumer acceptance between UKMRC9 and white rice

  2. Facilitators and Barriers to the Inclusion of UKMRC9 as a staple food

    Time frame: 24-week

    Participants' experience of substituting white rice with UKMRC9 explored through the focus group discussions.

  3. Dietary Pattern of Malaysian Adults with and without diabetes

    Time frame: 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.

  4. Diet Quality of Malaysian Adults with and without diabetes

    Time frame: 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.

  5. Changes in Advanced Glycation End (AGEs) products measured by skin autofluorescence using AGE Reader mu (Diagnostics).

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Taylor's University

Other

Collaborators

  • National Institutes of Health, Ministry of Health Malaysia
  • National University of Malaysia
  • Universiti Putra Malaysia
  • University of Nottingham Malaysia

Registry information

Official study title

A Randomized and Open Label Phase 2 Clinical Trial of Low-GI, Polyphenol-Rich UKMRC9 Red Rice on Cardiometabolic Parameters in Patients With Type 2 Diabetes

Acronym: RICH

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 19, 2024
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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