Rice Intervention in Chronic Health Study (RICH)

August 21, 2024 updated by: Tilakavati Karupaiah, Taylor's University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • Hospital Canselor Tuanku Muhriz
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • Klinik Kesihatan Cheras
    • Selangor
      • Bangi, Selangor, Malaysia, 43650
        • Klinik Kesihatan Bandar Baru Bangi
      • Kajang, Selangor, Malaysia, 43000
        • Klinik Kesihatan Kajang
      • Kajang, Selangor, Malaysia, 43000
        • Klinik Kesihatan Sungai Chua
      • Semenyih, Selangor, Malaysia, 43500
        • The University of Nottingham Malaysia Compus
      • Seri Kembangan, Selangor, Malaysia, 43400
        • Universiti Putra Malaysia
      • Seri Kembangan, Selangor, Malaysia, 43400
        • Hospital Pengajar Universiti Putra Malaysia
      • Shah Alam, Selangor, Malaysia, 40170
        • Institute for Medical Research
      • Subang Jaya, Selangor, Malaysia, 47500
        • Taylor's University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diabetes Patients Cohort Red Rice (DPC-RR)
Other: UKMRC9
UKMRC9 is a low glycemic index and polyphenol-rich red pigmented rice
Placebo Comparator: Diabetes Patients Cohort White Rice (DPC-WR)
Other: White rice
White rice refers to a local polished rice
Experimental: Healthy Control Cohort Red Rice (HCC-RR)
Other: UKMRC9
UKMRC9 is a low glycemic index and polyphenol-rich red pigmented rice
Placebo Comparator: Healthy Control Cohort White Rice (HCC-WR)
Other: White rice
White rice refers to a local polished rice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline versus 12-week versus 24-week
Changes in urinary and plasma metabolome
Time Frame: Baseline versus 12-week versus 24-week
Effects of UKMRC9 on urinary and plasma metabolome
Baseline versus 12-week versus 24-week
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
Baseline versus 24-week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consumer Acceptance Test
Time Frame: Baseline versus 12-week versus 24-week
Difference in consumer acceptance between UKMRC9 and white rice
Baseline versus 12-week versus 24-week
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.
24-week
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.
Baseline screening
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.
Baseline screening
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)
Baseline versus 12-week versus 24-week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taylor's University

Collaborators

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

Investigators

  • Principal Investigator: Tilakavati Karupaiah, PhD, Taylor's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2021

Primary Completion (Actual)

May 28, 2024

Study Completion (Actual)

August 12, 2024

Study Registration Dates

First Submitted

August 15, 2024

First Submitted That Met QC Criteria

August 15, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 26, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD0120Q1410

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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