Bromelain and Cardiovascular Risk Factors in Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- fibrinogen
研究概览
简要总结
The purpose of the study is to evaluate the effect of dietary supplementation of bromelain (a proteolytic enzyme from the pineapple plant) on the reduction of plasma fibrinogen level among type 2 diabetic subjects who have a high risk of cardiovascular disease.
The null hypothesis [Ho] is: there is no significant improvement in plasma fibrinogen, serum lipid profile, blood pressure, BMI, waist circumference and C-reactive protein for subjects with type 2 diabetes who are at risk of CVD following the intervention of bromelain supplementation compared to placebo group.
The alternative hypothesis [H1] is: there is a significant improvement in plasma fibrinogen, serum lipid profile, blood pressure, BMI, waist circumference and C-reactive protein for subjects with type 2 diabetes who are at risk of CVD following the intervention of bromelain supplementation compared to placebo group.
详细描述
According to American Heart Association (2010), heart disease and stroke are the No. 1 causes of death and disability among people with type 2 diabetes. At least 65% of people with diabetes die from some form of heart disease or stroke. Type 2 diabetes is associated with a two to fourfold increased incidence of ischemic cardiovascular events and markedly enhances the risk of stroke(Coutinho et al, 1999) due to a variety of associated risk factors that include high blood pressure, lipid disorders, high low-density lipoproteins (LDL) cholesterol, high triglycerides, low high-density lipoproteins (HDL) cholesterol, smoking, obesity, lack of physical activity and poorly controlled blood sugars(American Heart Association 2010).
Bromelain, a crude extract from the pineapple plant, was first introduced as a therapeutic compound in 1957 (Heinicke & Gortner, 1957). Heinicke et al. (1971) reported that bromelain was effective for use in cardiovascular diseases as an inhibitor of blood platelet aggregation, minimizing the risk of arterial thrombosis and embolism.
A literature review identified only three human studies (in Honolulu and Germany). In view of this review and the valuable therapeutic properties of bromelain to cardiovascular disease, there is a need for a study to confirm bromelain's use for cardiovasular disease.
This study is a randomized placebo control, parallel design, and double blind, pilot efficacy study which was carried out in Hebei Yiling Hospital, China. The study assessed the effects of 12 weeks of bromelain (1050mg/day) supplementation on plasma fibrinogen level compared to usual care. Study participants were type 2 diabetes who have a risk of developing cardiovascular disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age over 18 years old
- •Diagnosed type 2 diabetes (HbA1C at >6,5%), who are at a risk of CVD indicated with the following risk parameters:
- •total cholesterol between 5.0 - 6.2 mmol/l (195.0 - 241.8 mg/dL),
- •Body Mass Index (BMI) > 25 kg/m2
- •Waist circumference > 101.6 cm (40 inches) for men and > 88.9 cm (35 inches) for women
- •Triglycerides > 1.7 mmol/L (150mg/dL)
- •HDL-cholesterol < 1 mmol/L (40 mg/dL) for men, < 1.3 mmol/L (50 mg/dL) for women
- •LDL-cholesterol > 2.6 mmol/L (100 mg/dL)
- •Blood pressure > 140/90mm Hg
排除标准
- •Pregnant or trying to become pregnant or lactating women
- •Subjects unwilling or unable to comply with study procedure
- •Subjects with severe health problems including renal disease, liver disease, cardiovascular disease, and other chronic ill health conditions.
- •Subjects on drug cardiovascular medication like warfarin, aspirin.
- •Subjects that are taking statins.
- •Subjects taking bromelain supplement and other herbal supplements known to be effective e.g. cinnamon.
- •Subjects have a history of allergic reactions to bee stings, olive tree pollen or pineapple.
- •Subjects have a history of occupational inhalant/skin contact with bromelain.
- •Subjects have diabetes ketoacidosis recently (past 2 weeks).
- •Unable to provide informed consent i.e. unable to follow diet control advice or not willing to follow study procedure.
- •Subjects who is on any Chinese herbs medication
结局指标
主要结局
fibrinogen
时间窗: 12 weeks
This study is to assess the effects of 12 weeks of bromelain (1050mg/day) supplementation on plasma fibrinogen level compared to usual care.
次要结局
- Serum lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides)(12 weeks)
- HbA1c(12 weeks)
- C-reactive protein(12 weeks)
- Body Mass Index(12 weeks)
- Blood pressure(12 weeks)
- Alanine transaminase(12 weeks)
- Aspartate aminotransferase(12 weeks)
- blood urea nitrogen(12 weeks)
- Creatinine(12 weeks)
研究者
Ley Chit Moy (Kara)
PhD student
Hebei Yiling Hospital