Study Results
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Basic Information
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COMPLETED
NA
204 participants
INTERVENTIONAL
2021-05-28
2024-08-12
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Diabetes Patients Cohort Red Rice (DPC-RR)
UKMRC9
UKMRC9 is a low glycemic index and polyphenol-rich red pigmented rice
Diabetes Patients Cohort White Rice (DPC-WR)
White rice
White rice refers to a local polished rice
Healthy Control Cohort Red Rice (HCC-RR)
UKMRC9
UKMRC9 is a low glycemic index and polyphenol-rich red pigmented rice
Healthy Control Cohort White Rice (HCC-WR)
White rice
White rice refers to a local polished rice
Interventions
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UKMRC9
UKMRC9 is a low glycemic index and polyphenol-rich red pigmented rice
White rice
White rice refers to a local polished rice
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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:
* 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.
18 Years
60 Years
ALL
Yes
Sponsors
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National University of Malaysia
OTHER
Universiti Putra Malaysia
OTHER
National Institutes of Health, Ministry of Health Malaysia
OTHER
University of Nottingham Malaysia
OTHER
Taylor's University
OTHER
Responsible Party
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Tilakavati Karupaiah
Professor
Principal Investigators
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Tilakavati Karupaiah, PhD
Role: PRINCIPAL_INVESTIGATOR
Taylor's University
Locations
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Hospital Canselor Tuanku Muhriz
Cheras, Kuala Lumpur, Malaysia
Klinik Kesihatan Cheras
Cheras, Kuala Lumpur, Malaysia
Klinik Kesihatan Bandar Baru Bangi
Bangi, Selangor, Malaysia
Klinik Kesihatan Kajang
Kajang, Selangor, Malaysia
Klinik Kesihatan Sungai Chua
Kajang, Selangor, Malaysia
The University of Nottingham Malaysia Compus
Semenyih, Selangor, Malaysia
Hospital Pengajar Universiti Putra Malaysia
Seri Kembangan, Selangor, Malaysia
Universiti Putra Malaysia
Seri Kembangan, Selangor, Malaysia
Institute for Medical Research
Shah Alam, Selangor, Malaysia
Taylor's University
Subang Jaya, Selangor, Malaysia
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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RD0120Q1410
Identifier Type: -
Identifier Source: org_study_id
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