Cardiovascular Disease. Clinical Trial
Official title:
Bromelain and Cardiovascular Risk Factors in Diabetes
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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