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| Name | Class |
|---|---|
| National University of Malaysia | OTHER |
| Universiti Putra Malaysia | OTHER |
| National Institutes of Health, Ministry of Health Malaysia | OTHER |
| University of Nottingham Malaysia |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes Patients Cohort Red Rice (DPC-RR) | Experimental |
| |
| Diabetes Patients Cohort White Rice (DPC-WR) | Placebo Comparator |
| |
| Healthy Control Cohort Red Rice (HCC-RR) | Experimental |
| |
| Healthy Control Cohort White Rice (HCC-WR) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UKMRC9 | Other | UKMRC9 is a low glycemic index and polyphenol-rich red pigmented rice |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Consumer Acceptance Test | 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 |
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Diabetes Arm:
Inclusion Criteria:
Exclusion Criteria:
Healthy arm:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tilakavati Karupaiah, PhD | Taylor's University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Canselor Tuanku Muhriz | Cheras | Kuala Lumpur | 56000 | Malaysia | ||
| Klinik Kesihatan Cheras |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36167362 | Background | 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. | |
| 33905269 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| OTHER |
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Although the participants will not be blinded to the investigator product (IP), they will be masked from the brand of the IP.
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| White rice | Other | White rice refers to a local polished rice |
|
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 | 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 | 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). | 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 |
| Cheras |
| Kuala Lumpur |
| 56000 |
| Malaysia |
| Klinik Kesihatan Bandar Baru Bangi | Bangi | Selangor | 43650 | Malaysia |
| Klinik Kesihatan Kajang | Kajang | Selangor | 43000 | Malaysia |
| Klinik Kesihatan Sungai Chua | Kajang | Selangor | 43000 | Malaysia |
| The University of Nottingham Malaysia Compus | Semenyih | Selangor | 43500 | Malaysia |
| Hospital Pengajar Universiti Putra Malaysia | Seri Kembangan | Selangor | 43400 | Malaysia |
| Universiti Putra Malaysia | Seri Kembangan | Selangor | 43400 | Malaysia |
| Institute for Medical Research | Shah Alam | Selangor | 40170 | Malaysia |
| Taylor's University | Subang Jaya | Selangor | 47500 | Malaysia |
| 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. |
| 34123581 | 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. |
| 37676476 | 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. |
| 31006420 | 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. |
| D004700 | Endocrine System Diseases |