Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-03-01 @ 12:05 PM
Study NCT ID:
NCT04008693
Status:
COMPLETED
Last Update Posted:
2020-05-19
First Post:
2019-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aging, Aged Garlic, Vascular Function and Muscle Oxygenation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D056128', 'term': 'Obesity, Abdominal'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-15', 'studyFirstSubmitDate': '2019-06-19', 'studyFirstSubmitQcDate': '2019-07-03', 'lastUpdatePostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Near infrared spectroscopy 1', 'timeFrame': '180 minutes after nutritional intervention', 'description': 'microvascular endothelial function'}, {'measure': 'High performance liquid chromatography 1', 'timeFrame': 'Baseline and 180 minutes after nutritional intervention', 'description': 'Urinary nitrate concentrations'}, {'measure': 'High performance liquid chromatography 2', 'timeFrame': 'Baseline and 180 minutes after nutritional intervention', 'description': 'Urinary thiosulfate concetrations'}, {'measure': 'Near infrared spectroscopy 2', 'timeFrame': '180 minutes after nutritional intervention', 'description': 'muscle oxygenation saturated assessment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aging', 'Aged Garlic', 'Functional Food', 'Vascular Function', 'Muscle oxygenation', 'Exercise performance'], 'conditions': ['Aging', 'Hypertension', 'Dyslipidemias', 'Abdominal Obesity']}, 'referencesModule': {'references': [{'pmid': '35505122', 'type': 'DERIVED', 'citation': 'Leitao R, de Oliveira GV, Rezende C, Volino-Souza M, Mesquita J, de Carvalho LL, Alvares TS. Improved microvascular reactivity after aged garlic extract intake is not mediated by hydrogen sulfide in older adults at risk for cardiovascular disease: a randomized clinical trial. Eur J Nutr. 2022 Oct;61(7):3357-3366. doi: 10.1007/s00394-022-02895-y. Epub 2022 May 4.'}]}, 'descriptionModule': {'briefSummary': 'The number of elderly individuals affected by cardiovascular diseases has been increasing in our country. Garlic (Allium sativum) has been associated with decrease of reactive species of oxygen, hypertension, high cholesterol, platelet aggregation, blood coagulation and especially cardiovascular diseases. The present study evaluated the effects of a garlic supplementation on vascular function and blood pressure in the elderly at cardiometabolic risk. Twenty-eight elderly individuals were submitted to an ingestion of four capsules of an aged garlic extract (KYOLIC® Aged Garlic Extract™). Muscle oxygenation and function were measured 180 min after interventions. Urinary thiosulfate, blood nitrate, nitrite, systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were measured at baseline and 180 min after interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cardiometabolic risks\n* Cardiovascular diseases\n\nExclusion Criteria:\n\n* Cancer;\n* HIV positive;\n* Alcohol or drug abuse within the past 6 months previous the visit 1;\n* Garlic allergy;'}, 'identificationModule': {'nctId': 'NCT04008693', 'briefTitle': 'Aging, Aged Garlic, Vascular Function and Muscle Oxygenation', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do Rio de Janeiro'}, 'officialTitle': 'Effect of Aged Garlic on Vascular Function and Muscle Oxygenation Responses in the Elderly', 'orgStudyIdInfo': {'id': '86163618.5.0000.5699'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Kyolic® Hi-Po Formula - Kyolic', 'description': 'Aged garlic extract', 'interventionNames': ['Dietary Supplement: Aged Garlic Extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Maltodextrin', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Aged Garlic Extract', 'type': 'DIETARY_SUPPLEMENT', 'description': '2.400 mg (four capsules) of a nutritional supplement of aged garlic extract (Kyolic® Hi-Po Formula - Kyolic)', 'armGroupLabels': ['Kyolic® Hi-Po Formula - Kyolic']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '800 mg of maltodextrin (four capsules)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27930-560', 'city': 'Macaé', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Universidade Federal do Rio de Janeiro - Campus Macaé', 'geoPoint': {'lat': -22.38484, 'lon': -41.78324}}], 'overallOfficials': [{'name': 'Thiago Alvares', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidade Federal do Rio de Janeiro - Campus Macaé'}, {'name': 'Thiago Alvares', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Federal do Rio de Janeiro - Campus Macaé'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal do Rio de Janeiro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Thiago Alvares', 'investigatorAffiliation': 'Universidade Federal do Rio de Janeiro'}}}}