Status:
COMPLETED
Rice Intervention in Chronic Health Study
Lead Sponsor:
Taylor's University
Collaborating Sponsors:
National University of Malaysia
Universiti Putra Malaysia
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-60 years
Phase:
NA
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 dia...
Eligibility Criteria
Inclusion
- Diabetes Arm:
- 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
- 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.
Key Trial Info
Start Date :
May 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2024
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT06560541
Start Date
May 28 2021
End Date
August 12 2024
Last Update
August 26 2024
Active Locations (10)
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1
Hospital Canselor Tuanku Muhriz
Cheras, Kuala Lumpur, Malaysia, 56000
2
Klinik Kesihatan Cheras
Cheras, Kuala Lumpur, Malaysia, 56000
3
Klinik Kesihatan Bandar Baru Bangi
Bangi, Selangor, Malaysia, 43650
4
Klinik Kesihatan Kajang
Kajang, Selangor, Malaysia, 43000