Bromelain and Cardiovascular Risk Factors in Diabetes

Cardiovascular Disease. Clinical Trial

— BRCARDIO  

Official title:

Bromelain and Cardiovascular Risk Factors in Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01524159
• Other study ID #: BR2012
• Status: Completed
• Phase: N/A
• First received: January 30, 2012
• Last updated: September 20, 2012
• Start date: June 2011
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: Hebei Yiling Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease.
• Cardiovascular Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Hebei Yiling Hospital	Shijiazhuang	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Hebei Yiling Hospital	London South Bank University

Country where clinical trial is conducted

China, 

References & Publications (4)

American Heart Association. Prevention, Secondary. 2010. Available online at www.americanheart.org/print_presenter.jhtml [assessed 17th April 2010]

Coutinho M, Gerstein HC, Wang Y, Yusuf S. The relationship between glucose and incident cardiovascular events. A metaregression analysis of published data from 20 studies of 95,783 individuals followed for 12.4 years. Diabetes Care. 1999 Feb;22(2):233-40. — View Citation

Heinicke RM, van der Wal L, Yokoyama M. Effect of bromelain (Ananase) on human platelet aggregation. Experientia. 1972 Jul 15;28(7):844-5. — View Citation

Heinicke, R.M. & Gortner, W.A. 1957. Stem Bromelain - A New Protease Preparation from Pineapple Plants. Economic Botany, 11, 225-234

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fibrinogen	This study is to assess the effects of 12 weeks of bromelain (1050mg/day) supplementation on plasma fibrinogen level compared to usual care.	12 weeks	No
Secondary	Serum lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides)	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.	12 weeks	No
Secondary	HbA1c	This study is to assess the effects of 12 weeks of bromelain (1050mg/day) supplementation on changes of HbA1c compared to usual care.	12 weeks	No
Secondary	C-reactive protein	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.	12 weeks	No
Secondary	Body Mass Index	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.	12 weeks	No
Secondary	Blood pressure	This study is to assess the effects of 12 weeks of bromelain (1050mg/day) supplementation on changes of blood pressure compared to usual care.	12 weeks	No
Secondary	Alanine transaminase	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.	12 weeks	Yes
Secondary	Aspartate aminotransferase	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.	12 weeks	Yes
Secondary	blood urea nitrogen	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.	12 weeks	No
Secondary	Creatinine	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.	12 weeks	Yes