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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 204
- 试验地点
- 20
- 主要终点
- Changes in urinary and plasma metabolome
研究概览
简要总结
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:
- 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?
- What are the effects of substituting white rice with UKMRC9 on urinary and plasma metabolome in Malaysian adults T2D patients and healthy individuals?
- 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?
- What is the difference in consumer acceptance toward UKMRC9 compared to white rice?
- What are the facilitators and barriers to the inclusion of UKMRC9 as a staple food in Malaysian diet?
- What are the dietary quality and dietary pattern among Malaysian adults T2D patients and healthy individuals?
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Although the participants will not be blinded to the investigator product (IP), they will be masked from the brand of the IP.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Changes in urinary and plasma metabolome
时间窗: Baseline versus 12-week versus 24-week
Effects of UKMRC9 on urinary and plasma metabolome
Changes in mitochondrial DNA methylation and circulating miRNAs expression
时间窗: Baseline versus 24-week
Effects of UKMRC9 on mitochondrial DNA methylation and circulating miRNAs expression
Changes in cardio-metabolic parameters
时间窗: Baseline versus 12-week versus 24-week
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
次要结局
- Consumer Acceptance Test(Baseline versus 12-week versus 24-week)
- Facilitators and Barriers to the Inclusion of UKMRC9 as a staple food(24-week)
- Dietary Pattern of Malaysian Adults with and without diabetes(Baseline screening)
- Changes in Advanced Glycation End (AGEs) products measured by skin autofluorescence using AGE Reader mu (Diagnostics).(Baseline versus 12-week versus 24-week)
- Diet Quality of Malaysian Adults with and without diabetes(Baseline screening)
研究者
Tilakavati Karupaiah
Professor
Taylor's University