Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2026-01-03 @ 8:38 PM
Study NCT ID:
NCT03211767
Status:
COMPLETED
Last Update Posted:
2019-02-12
First Post:
2017-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Double-Blind, Randomized, Cross-Over Trial of Aged Garlic Extract for Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-09', 'studyFirstSubmitDate': '2017-01-03', 'studyFirstSubmitQcDate': '2017-07-05', 'lastUpdatePostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24 hour ambulatory blood pressure', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Blood total cholesterol', 'timeFrame': '8 weeks'}, {'measure': 'Blood low-density lipoprotein cholesterol', 'timeFrame': '8 weeks'}, {'measure': 'Blood high-density lipoprotein cholesterol', 'timeFrame': '8 weeks'}, {'measure': 'Blood triglycerides', 'timeFrame': '8 weeks'}, {'measure': 'Office blood pressure', 'timeFrame': '8 weeks'}, {'measure': 'Pulse wave velocity', 'timeFrame': '8 weeks', 'description': 'Measured by Mobil-O-Graph'}, {'measure': 'Augmentation index', 'timeFrame': '8 weeks', 'description': 'Measured by Mobil-O-Graph'}, {'measure': 'Body mass index', 'timeFrame': '8 weeks'}, {'measure': 'Waist circumference', 'timeFrame': '8 weeks'}, {'measure': 'Hip circumference', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial is to assess the effect of consumption of aged garlic extract powder on 24 h systolic and diastolic ambulatory blood pressure in hypertensive individuals following 8 weeks of supplementation.\n\nAdditional secondary objectives are to assess the effects of aged garlic extract powder intake for 8 weeks on lipid profile (TC, HDL-C, LDL-C, and TG concentrations), blood glucose, office blood pressure, pulse-wave velocity and augmentation index, body mass index, and waist and hip circumference.', 'detailedDescription': 'Forty hypertensive volunteers between 18 and 75 years will be recruited from the Winnipeg (Manitoba, Canada) area to participate in a two arm crossover, double-blind, randomized, placebo-controlled intervention study for 8 weeks per study period following obtainment of informed consent.\n\nThe 2 periods of treatment will include:\n\n1. Treatment period: One capsule twice a day, providing 600 mg each of aged garlic extract powder, for a total of 1200 mg/day of aged garlic extract powder.\n2. Control period: The control product will be an identical-looking placebo capsules containing cellulose, which is being used as a filler in the treatment capsules.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to give written informed consent.\n* Age: greater than or equal to 40 and less than or equal to 70 years.\n* Systolic blood pressure140-160mmHg and/or diastolic blood pressure 90-100 mmHg\n* LDL-C less than or equal to 4.9mmol/L\n* Those on a stable dose of blood pressure lowering or lipid-lowering medication for greater than or equal to 3 months; if a participant chooses to stop taking blood pressure lowering medications, they will be required to have a minimum 3 month washout period prior to commencement of the study; all other medications medications will be permitted if they are on a stable dose before the start of the study\n* Gender: Male and women who are not pregnant (determined by a negative urine pregnancy test at screening for women of childbearing potential) or lactating.\n* Language: Participants must be able to read, write and speak English.\n\nExclusion Criteria:\n\n* Systolic blood pressure \\> 160mmHg and/or diastolic blood pressure \\>100mmHg\n* Those currently taking (or have taken within the last 3 months) lipid-lowering or blood pressure-lowering supplements (i.e., omega-3 supplements, plant sterols/stanols foods and/or supplements, fibre, etc.)\n* Patients with unstable or serious illness, for example, dementia, terminal illness, recent bereavement, secondary hypertension, recent significant medical diagnosis.\n* History of cancer, chronic illness, cardiovascular problems, liver and kidney disease (including chronic kidney disease (GFR \\< 60ml/min/1.732)), diabetes, inflammatory bowel disease, pancreatitis, gallbladder or biliary disease, neurological/psychological disease, bleeding disorders, experienced platelet abnormalities, macrovascular target organ damage (including cerebrovascular disease, stroke, hypertensive retinopathy, left ventricular dysfunction, angina pectoris, myocardial infarction, and peripheral artery disease)\n* History of taking any type of garlic preparation (i.e., dried garlic homogenate, aged garlic extract, processed garlic capsule, time-released garlic powder tablet, regular garlic pill, garlic powder and garlic oil) in the past 6 months. in the past 3 months. (Note: regular garlic clove consumption as part of prepared meals, cooking preparations, etc. are permitted throughout the study period)\n* Plan to consume any type of garlic preparation (i.e., dried garlic homogenate, aged garlic extract, processed garlic capsule, time-released garlic powder tablet, regular garlic pill, garlic powder and garlic oil. at any time during the study. (Note: regular garlic clove consumption as part of prepared meals, cooking preparations, etc. are permitted throughout the study period)\n* Have gained or lost greater than or equal to 10lbs in the previous 3 months, or plan to lose weight at any time during the study\n* Plan to become pregnant during the study period.\n* Women of childbearing potential not using effective contraception which include: Hormonal contraceptives including combined oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormonal implants; Intrauterine devices (IUD) or Intrauterine system (IUS); Tubal ligation; Vasectomy of partner; Double barrier method (use of physical barrier by both partners, e.g. male condom and diaphragm, male condom and cervical cap)\n* Consumption of more than 2 alcoholic drinks/day, or \\> 14 alcoholic beverages a week, or history of alcoholism or drug dependence.\n* History of allergy to garlic, microcrystalline cellulose, silicon dioxide, magnesium stearate, gelatin, hydroxypropylcellulose, or caramel coloring\n* Any planned surgeries any time during the study\n* Taking medications with psychotropic properties for less than 3 months, i.e., those taking medications with psychotropic properties, such as anti-depressants, anti-anxiety, etc., at a stable consistent dose for a minimum of 3 months are eligible for the study, as long as the medication is consumed at a stable, consistent dose throughout the study period\n* Smokers\n* Exercising \\> 15 miles/wk or 4,000 kcal/wk'}, 'identificationModule': {'nctId': 'NCT03211767', 'briefTitle': 'Double-Blind, Randomized, Cross-Over Trial of Aged Garlic Extract for Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Double-Blind, Randomized, Cross-Over Trial of Aged Garlic Extract for Hypertension', 'orgStudyIdInfo': {'id': 'HS19581 (B2016:019)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Aged garlic extract', 'description': '2 capsules per day containing aged garlic extract', 'interventionNames': ['Dietary Supplement: Aged garlic extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '2 capsules per day without aged garlic extract', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Aged garlic extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Each capsule contains 600mg of aged garlic extract powder', 'armGroupLabels': ['Aged garlic extract']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Each capsule contains cellulose as a filler.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R3T 6C5', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Richardson Centre for Functional Foods and Nutraceuticals', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'overallOfficials': [{'name': 'Peter Jones, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manitoba'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wakunga of America Co. Ltd.', 'class': 'UNKNOWN'}, {'name': 'Purity Life Health Products LP', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}