NCT06560541Completed
Rice Intervention in Chronic Health Study
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
Source: ClinicalTrials.gov · Last updated 26 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 204 (actual)
- First submitted
- 15 Aug 2024
- Start date
- 28 May 2021
- Primary completion date
- 28 May 2024
- Lead sponsor
- Taylor's University
- Diseases
- Type 2 diabetes
- NCT number
- NCT06560541
What you commit to
- Study type: Interventional
- Participants enrolled: 204
- From 28 May 2021 to the primary completion date, 28 May 2024
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Oral corticosteroids \> 3 months
- Oral corticosteroids \> 3 months
Other illness
- Unstable medical condition.
- Presence of gastrointestinal disease, metabolic diseases such as diabetes, kidney failure, liver or pancreatic disease, hyperthyroidism, cancer or severe malnutrition.
Lab values
- Glycated hemoglobin (HbA1c) \<7% or \>10%
Other
- 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.
- 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.
- Healthy arm:
- Regular consumption of low-GI rice types (basmati) or colored rice (red rice, purple rice, black rice) for ≥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.
Who the study is looking for
- 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
- 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.
Criteria the registry did not label
- Diabetes Arm:
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Klinik Kesihatan Bandar Baru Bangi Coordinator of this site? Confirm its status | Bangi | Malaysia | Unknown status |
| Klinik Kesihatan Cheras Coordinator of this site? Confirm its status | Cheras | Malaysia | Unknown status |
| Hospital Canselor Tuanku Muhriz Coordinator of this site? Confirm its status | Cheras | Malaysia | Unknown status |
| Klinik Kesihatan Kajang Coordinator of this site? Confirm its status | Kajang | Malaysia | Unknown status |
| Klinik Kesihatan Sungai Chua Coordinator of this site? Confirm its status | Kajang | Malaysia | Unknown status |
| The University of Nottingham Malaysia Compus Coordinator of this site? Confirm its status | Semenyih | Malaysia | Unknown status |
| Universiti Putra Malaysia Coordinator of this site? Confirm its status | Seri Kembangan | Malaysia | Unknown status |
| Hospital Pengajar Universiti Putra Malaysia Coordinator of this site? Confirm its status | Seri Kembangan | Malaysia | Unknown status |
| Institute for Medical Research Coordinator of this site? Confirm its status | Shah Alam | Malaysia | Unknown status |
| Taylor's University Coordinator of this site? Confirm its status | Subang Jaya | Malaysia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.