Study Results
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Basic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2011-06-30
2011-12-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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London South Bank University
OTHER
Hebei Yiling Hospital
OTHER
Responsible Party
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Ley Chit Moy (Kara)
PhD student
Principal Investigators
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Ley C M, Ms
Role: PRINCIPAL_INVESTIGATOR
London South Bank University
Locations
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Hebei Yiling Hospital
Shijiazhuang, Beijing Municipality, China
Countries
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References
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American Heart Association. Prevention, Secondary. 2010. Available online at www.americanheart.org/print_presenter.jhtml [assessed 17th April 2010]
Heinicke, R.M. & Gortner, W.A. 1957. Stem Bromelain - A New Protease Preparation from Pineapple Plants. Economic Botany, 11, 225-234
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.
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.
Other Identifiers
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BR2012
Identifier Type: -
Identifier Source: org_study_id