Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-01-07 @ 12:22 AM
Study NCT ID:
NCT01524159
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2012-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bromelain and Cardiovascular Risk Factors in Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001963', 'term': 'Bromelains'}], 'ancestors': [{'id': 'D003546', 'term': 'Cysteine Endopeptidases'}, {'id': 'D057056', 'term': 'Cysteine Proteases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D010450', 'term': 'Endopeptidases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-20', 'studyFirstSubmitDate': '2012-01-30', 'studyFirstSubmitQcDate': '2012-01-30', 'lastUpdatePostDateStruct': {'date': '2012-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fibrinogen', 'timeFrame': '12 weeks', 'description': 'This study is to assess the effects of 12 weeks of bromelain (1050mg/day) supplementation on plasma fibrinogen level compared to usual care.'}], 'secondaryOutcomes': [{'measure': 'Serum lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides)', 'timeFrame': '12 weeks', 'description': '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.'}, {'measure': 'HbA1c', 'timeFrame': '12 weeks', 'description': 'This study is to assess the effects of 12 weeks of bromelain (1050mg/day) supplementation on changes of HbA1c compared to usual care.'}, {'measure': 'C-reactive protein', 'timeFrame': '12 weeks', 'description': '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.'}, {'measure': 'Body Mass Index', 'timeFrame': '12 weeks', 'description': '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.'}, {'measure': 'Blood pressure', 'timeFrame': '12 weeks', 'description': 'This study is to assess the effects of 12 weeks of bromelain (1050mg/day) supplementation on changes of blood pressure compared to usual care.'}, {'measure': 'Alanine transaminase', 'timeFrame': '12 weeks', 'description': '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.'}, {'measure': 'Aspartate aminotransferase', 'timeFrame': '12 weeks', 'description': '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.'}, {'measure': 'blood urea nitrogen', 'timeFrame': '12 weeks', 'description': '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.'}, {'measure': 'Creatinine', 'timeFrame': '12 weeks', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cardiovascular disease'], 'conditions': ['Cardiovascular Disease.']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'American Heart Association. Prevention, Secondary. 2010. Available online at www.americanheart.org/print_presenter.jhtml [assessed 17th April 2010]'}, {'type': 'BACKGROUND', 'citation': 'Heinicke, R.M. & Gortner, W.A. 1957. Stem Bromelain - A New Protease Preparation from Pineapple Plants. Economic Botany, 11, 225-234'}, {'pmid': '4658882', 'type': 'BACKGROUND', '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. doi: 10.1007/BF01923166. No abstract available.'}, {'pmid': '10333939', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe 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.', 'detailedDescription': "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).\n\nBromelain, 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.\n\nA 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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years old\n* Diagnosed type 2 diabetes (HbA1C at \\>6,5%), who are at a risk of CVD indicated with the following risk parameters:\n\n * total cholesterol between 5.0 - 6.2 mmol/l (195.0 - 241.8 mg/dL),\n * Body Mass Index (BMI) \\> 25 kg/m2\n * Waist circumference \\> 101.6 cm (40 inches) for men and \\> 88.9 cm (35 inches) for women\n * Triglycerides \\> 1.7 mmol/L (150mg/dL)\n * HDL-cholesterol \\< 1 mmol/L (40 mg/dL) for men, \\< 1.3 mmol/L (50 mg/dL) for women\n * LDL-cholesterol \\> 2.6 mmol/L (100 mg/dL)\n * Blood pressure \\> 140/90mm Hg\n\nExclusion Criteria:\n\n* Pregnant or trying to become pregnant or lactating women\n* Subjects unwilling or unable to comply with study procedure\n* Subjects with severe health problems including renal disease, liver disease, cardiovascular disease, and other chronic ill health conditions.\n* Subjects on drug cardiovascular medication like warfarin, aspirin.\n* Subjects that are taking statins.\n* Subjects taking bromelain supplement and other herbal supplements known to be effective e.g. cinnamon.\n* Subjects have a history of allergic reactions to bee stings, olive tree pollen or pineapple.\n* Subjects have a history of occupational inhalant/skin contact with bromelain.\n* Subjects have diabetes ketoacidosis recently (past 2 weeks).\n* Unable to provide informed consent i.e. unable to follow diet control advice or not willing to follow study procedure.\n* Subjects who is on any Chinese herbs medication'}, 'identificationModule': {'nctId': 'NCT01524159', 'acronym': 'BRCARDIO', 'briefTitle': 'Bromelain and Cardiovascular Risk Factors in Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Hebei Yiling Hospital'}, 'officialTitle': 'Bromelain and Cardiovascular Risk Factors in Diabetes', 'orgStudyIdInfo': {'id': 'BR2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group', 'description': '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.', 'interventionNames': ['Dietary Supplement: placebo (wheat starch)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bromelain group', 'description': '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.', 'interventionNames': ['Dietary Supplement: bromelain capsule']}], 'interventions': [{'name': 'bromelain capsule', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['bromelain group']}, {'name': 'placebo (wheat starch)', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050091', 'city': 'Shijiazhuang', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Hebei Yiling Hospital'}], 'overallOfficials': [{'name': 'Ley C M, Ms', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London South Bank University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hebei Yiling Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'London South Bank University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD student', 'investigatorFullName': 'Ley Chit Moy (Kara)', 'investigatorAffiliation': 'Hebei Yiling Hospital'}}}}