Bromelain and Cardiovascular Risk Factors in Diabetes

Not Applicable

Completed

• Conditions: Cardiovascular Disease.

• Registration Number: NCT01524159
• Lead Sponsor: Hebei Yiling Hospital

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 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.

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.

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-01
• Study First Submitted: 2012-01-30
• Study First Submitted QC: 2012-01-30
• Study First Posted: 2012-02-01
• Last Update Submitted: 2012-09-20
• Last Update Posted: 2012-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
fibrinogen	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 Outcome Measures

Name	Time	Method
Serum lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides)	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.
HbA1c	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.
C-reactive protein	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.
Body Mass Index	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.
Blood pressure	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.
Alanine transaminase	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.
Aspartate aminotransferase	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.
blood urea nitrogen	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.
Creatinine	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.

Trial Locations

Locations (1)

Hebei Yiling Hospital; 🇨🇳 Shijiazhuang, Beijing, China