Effectiveness Of 12-Weeks Brazilian Spinach on Health Outcomes Among Type 2 Diabetes Patients in Hospital Universiti Sains Malaysia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Fasting blood glucose
研究概览
简要总结
The purpose of this study is to determine whether Brazilian spinach supplementation effective in improving the nutritional status of Type 2 Diabetes Mellitus patient.
详细描述
Background: Vegetables are valuable health promotion foods because they contain vital nutrients such as vitamins, minerals, proteins, fibres and bio-functional components but are low in fat, sodium and calories as compared with many other foods. In terms of body fat, increase vegetable intake that consist of dietary fibre can play an important role in the regulation of body weight. Therefore, the supplementation of dietary fibre intake from vegetable may have benefit in reducing the percentages of body fat. Though, the clinical effect in human remains unclear and currently no study conducted in Malaysia regarding the effectiveness of this plant towards blood sugar control. Apart from that, lower intake of vegetable among Malaysian, lower cost vegetable choices and higher availability of Althernanthera Sissoo (Brazilian Spinach) due to easy growth may benefit the diabetes patient. Therefore, the investigators plan to conduct this study to determine the effectiveness of 12-weeks Brazilian Spinach supplementation on health outcomes among patients with type 2 diabetes especially in Kelantan region. The investigators hypothesized that diabetes patients on supplementation of Brazilian Spinach would have significant differ in terms of anthropometry, biochemical, clinical, and dietary intake compared to control group.
Method: A single-center randomized, controlled, and two-arm parallel design clinical trial will be carried out in Malaysia especially in Kelantan region. This study enrols 100 patients from Hospital Universiti Sains Malaysia (HUSM) diagnosed with type 2 diabetes. Diabetic patients who meet eligibility criteria will be randomly allocated to two groups, which are Brazilian Spinach treatment group and control group. Both groups will be compared on the primary and secondary outcomes at baseline, 3, 6, and 12 weeks.
Discussion: The study will provide insights into the potential beneficial effect of Brazilian Spinach in type 2 diabetic patients. In addition, the therapeutic effect of Brazilian Spinach towards type 2 diabetes will reflect as a change of metabolite profile in serum.
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
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 30-65 years old
- •Have confirmed diagnosed with type 2 diabetes mellitus of equal or more than 6 months
- •HbA1c levels equal or more than 7% (within the last 3 months of recruitment)
- •On at least one oral hypoglycemic agent
- •Agree not to take other herbal or nutritional supplements for the duration of study.
排除标准
- •Unable to tolerate to fiber especially vegetables
- •Type 1 diabetes mellitus
- •Insulin treatment
- •Severe diabetic complications including end-stage renal diseases, liver diseases or gastrointestinal diseases
- •On coagulant therapy (warfarin)
结局指标
主要结局
Fasting blood glucose
时间窗: 3 months
The outcome to be measured are the fasting blood glucose (FBS) in which it will be measured in mmol/L.
Glycaemic control (HbA1c level)
时间窗: 3 months
The outcome to be measured are the hbA1c level in which it will be measured in percentage.
次要结局
- Dietary Intake(3 months)
- Blood pressure(3 months)
- Anthropometric measurements(3 months)
- Liver profile(3 months)
- Renal profile(3 months)
研究者
Juliana binti Shamsudin
Principal Investigator
Universiti Sains Malaysia