Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-04 @ 11:54 PM
Study NCT ID:
NCT04434534
Status:
UNKNOWN
Last Update Posted:
2020-06-17
First Post:
2020-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Açaí Juçara Consumption on Endothelial Function and Arterial Stiffness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'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': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-12-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-12', 'studyFirstSubmitDate': '2020-06-12', 'studyFirstSubmitQcDate': '2020-06-12', 'lastUpdatePostDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flow-mediated Dilation (FMD)', 'timeFrame': '12 weeks', 'description': 'The non-invasive evaluation of endothelial function in the brachial artery will be performed at the Laboratory of Clinical Investigation of the Institute of Cardiology of Rio Grande do Sul. The images will be captured by a trained professional in the method using ultrasonography equipament with a linear transducer. The acquisition of the image will be through the program Ulead Video Studio (EasyCap). The protocol consist in 1 minute of baseline recording of the arterial flow diameter, followed by 5 minutes of reactive hyperemia (cuff occlusion in the forearm) and then 3 minutes recording after cuff deflation. The exams will be record in a video, and later analyzed through the Cardiovascular Suite software.\n\nThe FMD will be evaluated before the beginning of the diet and after 12 weeks of diet.'}], 'secondaryOutcomes': [{'measure': 'Pulse Wave Velocity', 'timeFrame': '12 weeks', 'description': 'The calibrated and validated Mobil-O-Graph® portable monitor will be used. This module is connected to a computer to record the brachial pulse wave. It performs pulse wave analysis based on the oscillometric method. The arterial pulsation generates pressure oscillations, which are transmitted to the blood pressure cuff and measured by the transducer to be interpreted by a specific software, recording the pulse wave of the brachial artery and deriving a pulse wave from the aortic arch.\n\nAll measurements will be performed by the same evaluator on the right side of the volunteer. Participants will be instructed to be in 12 hours os fasting.\n\nThe pulse wave velocity will be evaluated before the beginning of the diet and after 12 weeks of diet.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endhothelial function', 'Anthocyanins', 'Arterial stiffness', 'Açaí Juçara'], 'conditions': ['Overweight and Obesity']}, 'descriptionModule': {'briefSummary': 'This study evaluates the consumption of Açaí Juçara pulp in endothelial function and arterial stiffness in overwheight and obese individuals. Half of participants will receive a hipocaloric diet and two Açaí Juçara pulps for daily consumption, while the other half will receive just a hipocaloric diet.', 'detailedDescription': 'Obesity is the most prevalent nutritional disease and a growing public health problem worldwide. This clinical condition is an established risk factor for cardiovascular diseases.\n\nAçaí Juçara is a brazilian fruit, rich in antioxidants, like anthocyanin. This compound have antioxidative and vasodilatory properties. Prospective studies have shown that the antioxidant present in berries can improve vascular health, like endothelial function, measured by Flow Mediated Dilatation (FMD) and arterial stiffness, measured by Pulse Wave Velocity (PWV).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sedentary lifestyle\n* Overwheight or obesity "1" diagnostic (BMI \\>25kg/m² and \\<35kg/m²)\n\nExclusion Criteria:\n\n* Alcoolism\n* Smoking\n* Diagnostic of Diabetes Mellitus or Coronary Artery Disease\n* Use of Statin Therapy\n* Cardiovascular diseases\n* Infectious Disease'}, 'identificationModule': {'nctId': 'NCT04434534', 'briefTitle': 'Effect of Açaí Juçara Consumption on Endothelial Function and Arterial Stiffness', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Cardiologia do Rio Grande do Sul'}, 'officialTitle': 'Effect of Açaí Juçara Consumption on Endothelial Function and Arterial Stiffness in Overwheight or Obese Individuals: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '5483/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hipocaloric Diet with Açaí Juçara', 'description': 'Individualized diet plans calculated for each participant, reducing 500-1000 daily calories, including 200g of Açaí Juçara (2 pulps).', 'interventionNames': ['Dietary Supplement: Hipocaloric Diet with Açaí Juçara']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hipocaloric Diet', 'description': 'Individualized diet plans calculated for each participant, reducing 500-1000 daily calories.', 'interventionNames': ['Other: Hipocaloric Diet']}], 'interventions': [{'name': 'Hipocaloric Diet with Açaí Juçara', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily consumption of Açaí Juçara pulp (200g) and nutritional adequacy of meals in individualized diet plans calculated for each participant.', 'armGroupLabels': ['Hipocaloric Diet with Açaí Juçara']}, {'name': 'Hipocaloric Diet', 'type': 'OTHER', 'description': 'Nutritional adequacy of meals in individualized diet plans calculated for each participant.', 'armGroupLabels': ['Hipocaloric Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90620001', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Alexandre M Lehnen, PhD', 'role': 'CONTACT', 'email': 'amlehnen@gmail.com', 'phone': '+555199976809'}, {'name': 'Tainah Ortiz', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'centralContacts': [{'name': 'Tainah Ortiz', 'role': 'CONTACT', 'email': 'tainahortiz05@gmail.com', 'phone': '55 51 999171990'}, {'name': 'Alexandre Lehnen, PhD', 'role': 'CONTACT', 'email': 'amlehnen@gmail.com', 'phone': '55 51 999768092'}], 'overallOfficials': [{'name': 'Tainah Ortiz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto de Cardiologia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Cardiologia do Rio Grande do Sul', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}