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Completed

NCT Number: NCT01524159

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hebei Yiling Hospital

Shijiazhuang, Beijing Municipality, 050091, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bromelain capsule

Dietary Supplement

Bromelain group received 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.

placebo (wheat starch)

Dietary Supplement

Placebo group received 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.

Primary outcomes

  1. fibrinogen

    Time frame: 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.

Secondary outcomes

  1. Serum lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides)

    Time frame: 12 weeks

    This study is to assess the effects of 12 weeks of bromelain (1050mg/day) supplementation on changes of serum lipid profile compared to usual care.

  2. HbA1c

    Time frame: 12 weeks

    This study is to assess the effects of 12 weeks of bromelain (1050mg/day) supplementation on changes of HbA1c compared to usual care.

  3. C-reactive protein

    Time frame: 12 weeks

    This study is to assess the effects of 12 weeks of bromelain (1050mg/day) supplementation on changes of C-reactive protein compared to usual care.

  4. Body Mass Index

    Time frame: 12 weeks

    This study is to assess the effects of 12 weeks of bromelain (1050mg/day) supplementation on changes of body mass index compared to usual care.

  5. Blood pressure

    Time frame: 12 weeks

    This study is to assess the effects of 12 weeks of bromelain (1050mg/day) supplementation on changes of blood pressure compared to usual care.

  6. Alanine transaminase

    Time frame: 12 weeks

    This study is to assess the effect of 12 weeks of bromelain (1050mg/day) supplementation on changes of alanine transaminase (for liver function test) compared to usual care.

  7. Aspartate aminotransferase

    Time frame: 12 weeks

    This study is to assess the effect of 12 weeks of bromelain (1050mg/day) supplementation on changes of aspartate aminotransferase(for liver function test) compared to usual care.

  8. blood urea nitrogen

    Time frame: 12 weeks

    This study is to assess the changes of 12 weeks of bromelain (1050mg/day) supplementation on blood urea nitrogen(for kidney function test) compared to usual care.

  9. Creatinine

    Time frame: 12 weeks

    This study is to assess the effect of 12 weeks of bromelain (1050mg/day) supplementation on changes of creatinine(for kidney function test) compared to usual care.

Sponsors and collaborators

Lead sponsor

Hebei Yiling Hospital

Other

Collaborators

  • London South Bank University

Registry information

Acronym: BRCARDIO

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 1, 2012
Registry last updated
Sep 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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