Rice Intervention in Chronic Health Study

NCT06560541 | Completed

• 1 other identifier: RD0120Q1410
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 10

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:

• 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Pigmented rice; Whole grain rice; Type 2 diabetes; Cardio-metabolic health; Mitochondrial DNA methylation; Circulating exosomal miRNA; Metabolomics; Consumer acceptance test

Outcome Measures

Primary Outcomes (3)

• Changes in cardio-metabolic parameters

  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

  Effects of UKMRC9 on urinary and plasma metabolome

  Baseline versus 12-week versus 24-week

• Changes in mitochondrial DNA methylation and circulating miRNAs expression

  Effects of UKMRC9 on mitochondrial DNA methylation and circulating miRNAs expression

  Baseline versus 24-week

Secondary Outcomes (5)

• Consumer Acceptance Test

  Baseline versus 12-week versus 24-week

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

  24-week

• Dietary Pattern of Malaysian Adults with and without diabetes

  Baseline screening

• Diet Quality of Malaysian Adults with and without diabetes

  Baseline screening

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

  Baseline versus 12-week versus 24-week

Study Arms (4)

Diabetes Patients Cohort Red Rice (DPC-RR)

EXPERIMENTAL

Other: UKMRC9

Diabetes Patients Cohort White Rice (DPC-WR)

PLACEBO COMPARATOR

Other: White rice

Healthy Control Cohort Red Rice (HCC-RR)

EXPERIMENTAL

Other: UKMRC9

Healthy Control Cohort White Rice (HCC-WR)

PLACEBO COMPARATOR

Other: White rice

Interventions

UKMRC9 OTHER

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

Diabetes Patients Cohort Red Rice (DPC-RR); Healthy Control Cohort Red Rice (HCC-RR)

White rice OTHER

White rice refers to a local polished rice

Diabetes Patients Cohort White Rice (DPC-WR); Healthy Control Cohort White Rice (HCC-WR)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Healthy free living
• With glycated haemoglobin (HbA1c \<6.3%)
• Age 18 - 60 years (i.e. adult population)

Sponsors & Collaborators

• Taylor's University: lead
• National University of Malaysia: collaborator
• Universiti Putra Malaysia: collaborator
• National Institutes of Health, Ministry of Health Malaysia: collaborator
• University of Nottingham Malaysia: collaborator

Study Sites (10)

Hospital Canselor Tuanku Muhriz

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Klinik Kesihatan Cheras

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Klinik Kesihatan Bandar Baru Bangi

Bangi, Selangor, 43650, Malaysia

Location

Klinik Kesihatan Kajang

Kajang, Selangor, 43000, Malaysia

Location

Klinik Kesihatan Sungai Chua

Kajang, Selangor, 43000, Malaysia

Location

The University of Nottingham Malaysia Compus

Semenyih, Selangor, 43500, Malaysia

Location

Hospital Pengajar Universiti Putra Malaysia

Seri Kembangan, Selangor, 43400, Malaysia

Location

Universiti Putra Malaysia

Seri Kembangan, Selangor, 43400, Malaysia

Location

Institute for Medical Research

Shah Alam, Selangor, 40170, Malaysia

Location

Taylor's University

Subang Jaya, Selangor, 47500, Malaysia

Location

Related Publications (5)

• Yu J, Balaji B, Tinajero M, Jarvis S, Khan T, Vasudevan S, Ranawana V, Poobalan A, Bhupathiraju S, Sun Q, Willett W, Hu FB, Jenkins DJA, Mohan V, Malik VS. White rice, brown rice and the risk of type 2 diabetes: a systematic review and meta-analysis. BMJ Open. 2022 Sep 27;12(9):e065426. doi: 10.1136/bmjopen-2022-065426.

  PMID: 36167362 BACKGROUND

• Golzarand M, Toolabi K, Eskandari Delfan S, Mirmiran P. The effect of brown rice compared to white rice on adiposity indices, lipid profile, and glycemic markers: a systematic review and meta-analysis of randomized controlled trials. Crit Rev Food Sci Nutr. 2022;62(27):7395-7412. doi: 10.1080/10408398.2021.1914541. Epub 2021 Apr 27.

  PMID: 33905269 BACKGROUND

• Abdul Rahim AF, Norhayati MN, Zainudin AM. The effect of a brown-rice diets on glycemic control and metabolic parameters in prediabetes and type 2 diabetes mellitus: a meta-analysis of randomized controlled trials and controlled clinical trials. PeerJ. 2021 May 26;9:e11291. doi: 10.7717/peerj.11291. eCollection 2021.

  PMID: 34123581 BACKGROUND

• Mendoza-Sarmiento D, Mistades EV, Hill AM. Effect of Pigmented Rice Consumption on Cardiometabolic Risk Factors: A Systematic Review of Randomized Controlled Trials. Curr Nutr Rep. 2023 Dec;12(4):797-812. doi: 10.1007/s13668-023-00496-7. Epub 2023 Sep 7.

  PMID: 37676476 BACKGROUND

• Malik VS, Sudha V, Wedick NM, RamyaBai M, Vijayalakshmi P, Lakshmipriya N, Gayathri R, Kokila A, Jones C, Hong B, Li R, Krishnaswamy K, Anjana RM, Spiegelman D, Willett WC, Hu FB, Mohan V. Substituting brown rice for white rice on diabetes risk factors in India: a randomised controlled trial. Br J Nutr. 2019 Jun;121(12):1389-1397. doi: 10.1017/S000711451900076X. Epub 2019 Apr 22.

  PMID: 31006420 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Tilakavati Karupaiah, PhD

  Taylor's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Although the participants will not be blinded to the investigator product (IP), they will be masked from the brand of the IP.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: May 28, 2021
• Primary Completion: May 28, 2024
• Study Completion: August 12, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (10)