Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-24 @ 2:38 PM
NCT ID:
NCT01524159
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01524159
Study Brief:
Protocol Section:
NCT01524159