Bromelain and Cardiovascular Risk Factors in Diabetes (BRCARDIO)

This study has been completed.
Sponsor:
Collaborator:
London South Bank University
Information provided by (Responsible Party):
Ley Chit Moy (Kara), Hebei Yiling Hospital
ClinicalTrials.gov Identifier:
NCT01524159
First received: January 30, 2012
Last updated: September 20, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Cardiovascular Disease.
Dietary Supplement: bromelain capsule
Dietary Supplement: placebo (wheat starch)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Bromelain and Cardiovascular Risk Factors in Diabetes

Resource links provided by NLM:


Further study details as provided by Hebei Yiling Hospital:

Primary Outcome Measures:
  • fibrinogen [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    This study is to assess the effects of 12 weeks of bromelain (1050mg/day) supplementation on plasma fibrinogen level compared to usual care.


Secondary Outcome Measures:
  • Serum lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    This study is to assess the effects of 12 weeks of bromelain (1050mg/day) supplementation on changes of HbA1c compared to usual care.

  • C-reactive protein [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Body Mass Index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Blood pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    This study is to assess the effects of 12 weeks of bromelain (1050mg/day) supplementation on changes of blood pressure compared to usual care.

  • Alanine transaminase [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Aspartate aminotransferase [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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.

  • blood urea nitrogen [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Creatinine [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 72
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo group
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.
Dietary Supplement: placebo (wheat starch)
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.
Active Comparator: bromelain group
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.
Dietary Supplement: bromelain capsule
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.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01524159

Locations
China, Beijing
Hebei Yiling Hospital
Shijiazhuang, Beijing, China, 050091
Sponsors and Collaborators
Hebei Yiling Hospital
London South Bank University
Investigators
Principal Investigator: Ley C M, Ms London South Bank University
  More Information

Publications:
Responsible Party: Ley Chit Moy (Kara), PhD student, Hebei Yiling Hospital
ClinicalTrials.gov Identifier: NCT01524159     History of Changes
Other Study ID Numbers: BR2012
Study First Received: January 30, 2012
Last Updated: September 20, 2012
Health Authority: China: Ethics Committee

Keywords provided by Hebei Yiling Hospital:
cardiovascular disease

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014