Bromelain and Cardiovascular Risk Factors in Diabetes (BRCARDIO)

Hebei Yiling Hospital

Status: Completed

Conditions: Cardiovascular Disease.

Treatments: Dietary Supplement: placebo (wheat starch); Dietary Supplement: bromelain capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT01524159

BR2012

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

placebo group

Placebo Comparator group

Description:

This group will receive placebo capsule (wheat starch) for 12 weeks period. The 1050 mg dosage of wheat starch was divided into three capsules and to be taken two (2 x 350 mg) after breakfast and another one (350 mg) after dinner. The capsules should be taken two hours after the meals.

Treatment:

Dietary Supplement: placebo (wheat starch)

bromelain group

Active Comparator group

Description:

Bromelain Group This group will receive bromelain capsule for 12 weeks period. The 1050 mg dosage of bromelain was divided into three capsules and to be taken two (2 x 350 mg) after breakfast and another one (350 mg) after dinner. The capsules should be taken two hours after the meals.

Treatment:

Dietary Supplement: bromelain capsule