Clinical trial NCT06560541: Rice Intervention in Chronic Health 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Taylor's University
Sponsor class: OTHER
Collaborators: name: National University of Malaysia
name: Universiti Putra Malaysia
name: National Institutes of Health, Ministry of Health Malaysia
name: University of Nottingham Malaysia
First posted: 2024-08-19
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in cardio-metabolic parameters
timeFrame: Baseline versus 12-week versus 24-week
measure: Changes in urinary and plasma metabolome
timeFrame: Baseline versus 12-week versus 24-week
measure: Changes in mitochondrial DNA methylation and circulating miRNAs expression
timeFrame: Baseline versus 24-week
Secondary outcomes:
measure: Consumer Acceptance Test
timeFrame: Baseline versus 12-week versus 24-week
measure: Facilitators and Barriers to the Inclusion of UKMRC9 as a staple food
timeFrame: 24-week
measure: Dietary Pattern of Malaysian Adults with and without diabetes
timeFrame: Baseline screening
measure: Diet Quality of Malaysian Adults with and without diabetes
timeFrame: Baseline screening
measure: Changes in Advanced Glycation End (AGEs) products measured by skin autofluorescence using AGE Reader mu (Diagnostics).
timeFrame: Baseline versus 12-week versus 24-week
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: Hospital Canselor Tuanku Muhriz
state: Kuala Lumpur
city: Cheras
country: Malaysia
facility: Klinik Kesihatan Cheras
state: Kuala Lumpur
city: Bangi
country: Malaysia
facility: Klinik Kesihatan Bandar Baru Bangi
state: Selangor
city: Kajang
country: Malaysia
facility: Klinik Kesihatan Kajang
state: Selangor
city: Kajang
country: Malaysia
facility: Klinik Kesihatan Sungai Chua
state: Selangor
city: Semenyih
country: Malaysia
facility: The University of Nottingham Malaysia Compus
state: Selangor
city: Seri Kembangan
country: Malaysia
facility: Hospital Pengajar Universiti Putra Malaysia
state: Selangor
city: Seri Kembangan
country: Malaysia
facility: Universiti Putra Malaysia
state: Selangor
city: Shah Alam
country: Malaysia
facility: Institute for Medical Research
state: Selangor
city: Subang Jaya
country: Malaysia
facility: Taylor's University
state: Selangor
Study officials:
affiliation: Taylor's University
name: Tilakavati Karupaiah, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.