Status:
COMPLETED
Bromelain and Cardiovascular Risk Factors in Diabetes
Lead Sponsor:
Hebei Yiling Hospital
Collaborating Sponsors:
London South Bank University
Conditions:
Cardiovascular Disease.
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 diab...
Detailed Description
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 s...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01524159
Start Date
June 1 2011
End Date
December 1 2011
Last Update
September 24 2012
Active Locations (1)
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1
Hebei Yiling Hospital
Shijiazhuang, Beijing Municipality, China, 050091