NCT01524159

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
Last Updated

September 24, 2012

Status Verified

January 1, 2012

Enrollment Period

6 months

First QC Date

January 30, 2012

Last Update Submit

September 20, 2012

Conditions

Cardiovascular Disease.

Keywords

cardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

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

    12 weeks

  • HbA1c

    12 weeks

  • C-reactive protein

    12 weeks

  • Body Mass Index

    12 weeks

  • Blood pressure

    12 weeks

  • +4 more secondary outcomes

Study Arms (2)

placebo group

PLACEBO COMPARATOR

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)

bromelain group

ACTIVE COMPARATOR

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

Interventions

bromelain capsuleDIETARY_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.

bromelain group
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.

placebo group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebei Yiling Hospital

Shijiazhuang, Beijing Municipality, 050091, China

Location

Related Publications (4)

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

    BACKGROUND

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

    BACKGROUND

  • Heinicke RM, van der Wal L, Yokoyama M. Effect of bromelain (Ananase) on human platelet aggregation. Experientia. 1972 Jul 15;28(7):844-5. doi: 10.1007/BF01923166. No abstract available.

    PMID: 4658882BACKGROUND

  • 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. doi: 10.2337/diacare.22.2.233.

    PMID: 10333939BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Bromelains

Intervention Hierarchy (Ancestors)

Cysteine EndopeptidasesCysteine ProteasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesEndopeptidases

Study Officials

  • Ley C M, Ms

    London South Bank University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

January 30, 2012

First Posted

February 1, 2012

Study Start

June 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

September 24, 2012

Record last verified: 2012-01

Locations

CN(1)