Diabetes Mellitus, Type 2RICHNCT06560541
Rice Intervention in Chronic Health Study
A study testing UKMRC9 and White rice in people with Diabetes Mellitus, Type 2, run by Taylor's University at 10 sites in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- UKMRC9 and White rice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 10 sitesMalaysia
- Study dates
- 28 May 2021to 12 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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%
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- Willing to take part and being compliant to the study protocol
- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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:
- 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 locations and contacts
10 sites in 1 country.
10 sites in 1 country
Malaysia10 sites
Klinik Kesihatan Bandar Baru Bangi
Bangi, Selangor, 43650
Hospital Canselor Tuanku Muhriz
Cheras, Kuala Lumpur, 56000
Klinik Kesihatan Cheras
Cheras, Kuala Lumpur, 56000
Klinik Kesihatan Kajang
Kajang, Selangor, 43000
Klinik Kesihatan Sungai Chua
Kajang, Selangor, 43000
The University of Nottingham Malaysia Compus
Semenyih, Selangor, 43500
Hospital Pengajar Universiti Putra Malaysia
Seri Kembangan, Selangor, 43400
Universiti Putra Malaysia
Seri Kembangan, Selangor, 43400
Institute for Medical Research
Shah Alam, Selangor, 40170
Taylor's University
Subang Jaya, Selangor, 47500
About this study
Official 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
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:
- 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?
- What are the effects of substituting white rice with UKMRC9 on urinary and plasma metabolome in Malaysian adults T2D patients and healthy individuals?
- 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?
- What is the difference in consumer acceptance toward UKMRC9 compared to white rice?
- What are the facilitators and barriers to the inclusion of UKMRC9 as a staple food in Malaysian diet?
- What are the dietary quality and dietary pattern among Malaysian adults T2D patients and healthy individuals?
- What is the effects of substituting white rice with UKMRC9 on advanced glycation end (AGE) products among Malaysian adults T2D patients and healthy individuals?
Read more
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- UKMRC9, White rice
- Keywords
- Pigmented rice, Whole grain rice, Type 2 diabetes, Cardio-metabolic health, Mitochondrial DNA methylation, Circulating exosomal miRNA, Metabolomics, Consumer acceptance test
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UKMRC9Other
UKMRC9 is a low glycemic index and polyphenol-rich red pigmented rice
White riceOther
White rice refers to a local polished rice
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Patients Cohort Red Rice (DPC-RR) | Experimental | Not described Receives: Other: UKMRC9 |
| Diabetes Patients Cohort White Rice (DPC-WR) | Placebo comparator | Not described Receives: Other: White rice |
| Healthy Control Cohort Red Rice (HCC-RR) | Experimental | Not described Receives: Other: UKMRC9 |
| Healthy Control Cohort White Rice (HCC-WR) | Placebo comparator | Not described Receives: Other: White rice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline versus 12-week versus 24-week
Changes in urinary and plasma metabolome
Effects of UKMRC9 on urinary and plasma metabolome
Measured: 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
Measured: Baseline versus 24-week
Secondary outcomes (5)
Consumer Acceptance Test
Difference in consumer acceptance between UKMRC9 and white rice
Measured: Baseline versus 12-week versus 24-week
Facilitators and Barriers to the Inclusion of UKMRC9 as a staple food
Participants' experience of substituting white rice with UKMRC9 explored through the focus group discussions.
Measured: 24-week
Dietary Pattern of Malaysian Adults with and without diabetes
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.
Measured: Baseline screening
Diet Quality of Malaysian Adults with and without diabetes
Diet quality will be benchmarked using the Healthy Eating Index (ranging from 0 to 100%), where a higher index indicates better diet quality.
Measured: Baseline screening
Changes in Advanced Glycation End (AGEs) products measured by skin autofluorescence using AGE Reader mu (Diagnostics).
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)
Measured: Baseline versus 12-week versus 24-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start28 May 2021
- Primary completion28 May 2024
- Study completion12 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taylor's University
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Malaysia, Universiti Putra Malaysia, National Institutes of Health, Ministry of Health Malaysia, University of Nottingham Malaysia
- Responsible party
- Principal investigator, Tilakavati Karupaiah, Taylor's University
- Investigators
- Tilakavati Karupaiah, PhD, Principal investigator, Taylor's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560541
- Sponsor's protocol ID
- RD0120Q1410
- Acronym
- RICH
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36167362Golzarand 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.
PubMed 33905269Abdul 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.
PubMed 34123581Mendoza-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.
PubMed 37676476Malik 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.
PubMed 31006420
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06560541
- Acronym / sponsor ID
- RICH / RD0120Q1410
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Taylor's UniversityUniversity, hospital or other
- Collaborators
- National University of Malaysia, Universiti Putra Malaysia, National Institutes of Health, Ministry of Health Malaysia, University of Nottingham Malaysia
- Study start
- 28 May 2021 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 12 Aug 2024 (actual)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- What are the effects of substituting white rice with UKMRC9 on urinary and plasma metabolome in Malaysian adults T2D patients and healthy individuals?
- 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?
- What is the difference in consumer acceptance toward UKMRC9 compared to white rice?
- What are the facilitators and barriers to the inclusion of UKMRC9 as a staple food in Malaysian diet?
- What are the dietary quality and dietary pattern among Malaysian adults T2D patients and healthy individuals?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UKMRC9UKMRC9 is a low glycemic index and polyphenol-rich red pigmented rice | Other | Diabetes Patients Cohort Red Rice (DPC-RR), Healthy Control Cohort Red Rice (HCC-RR) |
| White riceWhite rice refers to a local polished rice | Other | Diabetes Patients Cohort White Rice (DPC-WR), Healthy Control Cohort White Rice (HCC-WR) |
Primary outcome
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
Changes in urinary and plasma metabolome
Time frame: Baseline versus 12-week versus 24-week
Effects of UKMRC9 on urinary and plasma metabolome
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
5 secondary outcomes
Consumer Acceptance Test
Time frame: Baseline versus 12-week versus 24-week
Facilitators and Barriers to the Inclusion of UKMRC9 as a staple food
Time frame: 24-week
Dietary Pattern of Malaysian Adults with and without diabetes
Time frame: Baseline screening
Diet Quality of Malaysian Adults with and without diabetes
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Background: PubMed 36167362Yu 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.
- Background: PubMed 33905269Golzarand 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.
- Background: PubMed 34123581Abdul 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.
- Background: PubMed 37676476Mendoza-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.
- Background: PubMed 31006420Malik 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tilakavati Karupaiah, PhD principal investigator
Taylor's University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UKMRC9 and White rice in people with Diabetes Mellitus, Type 2, run by Taylor's University at 10 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cardio-metabolic parameters (time frame: Baseline versus 12-week versus 24-week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06560541, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.