Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2025-12-27 @ 10:14 PM
Study NCT ID:
NCT04781595
Status:
COMPLETED
Last Update Posted:
2022-12-22
First Post:
2021-02-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Watermelon and Beetroot Products on Endothelial Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-21', 'studyFirstSubmitDate': '2021-02-23', 'studyFirstSubmitQcDate': '2021-03-01', 'lastUpdatePostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flow-mediated dilation (FMD)', 'timeFrame': 'This measure will be evaluate before the nutritional intervention'}, {'measure': 'Flow-mediated dilation (FMD)', 'timeFrame': 'This measure will be evaluate 60 minutes after the nutritional intervention'}, {'measure': 'Flow-mediated dilation (FMD)', 'timeFrame': 'This measure will be evaluate 120 minutes after the nutritional intervention'}, {'measure': 'Muscle oxygen saturation', 'timeFrame': 'This measure will be evaluate before the nutritional intervention'}, {'measure': 'Muscle oxygen saturation', 'timeFrame': 'This measure will be evaluate 30 minutes after the nutritional intervention'}, {'measure': 'Muscle oxygen saturation', 'timeFrame': 'This measure will be evaluate 60 minutes after the nutritional intervention'}, {'measure': 'Muscle oxygen saturation', 'timeFrame': 'This measure will be evaluate 90 minutes after the nutritional intervention'}, {'measure': 'Muscle oxygen saturation', 'timeFrame': 'This measure will be evaluate 120 minutes after the nutritional intervention'}], 'secondaryOutcomes': [{'measure': 'Plasmatic amino acids', 'timeFrame': 'This measure will be evaluate before the nutritional intervention'}, {'measure': 'Plasmatic amino acids', 'timeFrame': 'This measure will be evaluate 30 minutes after the nutritional intervention'}, {'measure': 'Plasmatic amino acids', 'timeFrame': 'This measure will be evaluate 60 minutes after the nutritional intervention'}, {'measure': 'Plasmatic amino acids', 'timeFrame': 'This measure will be evaluate 90 minutes after the nutritional intervention'}, {'measure': 'Plasmatic amino acids', 'timeFrame': 'This measure will be evaluate 120 minutes after the nutritional intervention'}, {'measure': 'Plasmatic glucose', 'timeFrame': 'This measure will be evaluate before the nutritional intervention'}, {'measure': 'Plasmatic glucose', 'timeFrame': 'This measure will be evaluate 30 min after the nutritional intervention'}, {'measure': 'Plasmatic glucose', 'timeFrame': 'This measure will be evaluate 60 min after the nutritional intervention'}, {'measure': 'Plasmatic glucose', 'timeFrame': 'This measure will be evaluate 90 min after the nutritional intervention'}, {'measure': 'Plasmatic glucose', 'timeFrame': 'This measure will be evaluate 120 min after the nutritional intervention'}, {'measure': 'Plasmatic insulin', 'timeFrame': 'This measure will be evaluate before the nutritional intervention'}, {'measure': 'Plasmatic insulin', 'timeFrame': 'This measure will be evaluate 30 min after the nutritional intervention'}, {'measure': 'Plasmatic insulin', 'timeFrame': 'This measure will be evaluate 60 min after the nutritional intervention'}, {'measure': 'Plasmatic insulin', 'timeFrame': 'This measure will be evaluate 90 min after the nutritional intervention'}, {'measure': 'Plasmatic insulin', 'timeFrame': 'This measure will be evaluate 120 min after the nutritional intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endothelial function', 'L-citrulline', 'nitrate', 'nitric oxide'], 'conditions': ['Healthy Young', 'Older People With Cardiovascular Disease Risk']}, 'referencesModule': {'references': [{'pmid': '37561087', 'type': 'DERIVED', 'citation': 'Volino-Souza M, Oliveira GV, Tavares AC, Souza K, Alvares T. The effect of microencapsulated watermelon rind (Citrullus lanatus) and beetroot (Beta vulgaris L.) ingestion on ischemia/reperfusion-induced endothelial dysfunction: a randomised clinical trial. Food Funct. 2023 Aug 29;14(17):7959-7968. doi: 10.1039/d3fo02612d.'}, {'pmid': '36109652', 'type': 'DERIVED', 'citation': 'Volino-Souza M, de Oliveira GV, Conte-Junior CA, Alvares TS. Effect of microencapsulated watermelon (Citrullus Lanatus) rind on flow-mediated dilation and tissue oxygen saturation of young adults. Eur J Clin Nutr. 2023 Jan;77(1):71-74. doi: 10.1038/s41430-022-01200-8. Epub 2022 Sep 15.'}]}, 'descriptionModule': {'briefSummary': 'Cardiovascular disease is the main cause of death worldwide. Endothelial dysfunction is the first step to development of cardiovascular diseases. Endothelial dysfunction occurs due to reduction in nitric oxide, a molecule that plays an important role on vascular health. Due to important role of nitric oxide in endothelial function, several studies have evaluated the effect of its precursors, such as L-citrulline and nitrate on endothelial function parameters. The present study will evaluate the effect of L-citrulline and nitrate derived by watermelon and beetroot products, respectively, on endothelial function of young and older participants. Furthermore, we will evaluate the plasmatic amino acids, nitrate, glucose and insulin in response to ingestion of these products.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for healthy young participants:\n\n* Age between 18-35 years;\n* Triglycerides ≤ 150 mg/dL\n* HDL-cholesterol ≥ 50 mg/dL for women and ≥ 40 mg/dL for men;\n* Waist circumference ≤ 102 cm for men and ≤ 88 cm for women).\n\nInclusion Criteria for older people with cardiovascular risk:\n\n* Age ≥ 60 years;\n* Elevated triglycerides ≥150 mg/dL;\n* Reduced HDL-cholesterol ≤ 50 mg/dL for women and ≤ 40 mg/dL for men;\n* Elevated waist circumference ≥102 cm for men and ≥ 88 cm for women).\n\nExclusion Criteria:\n\n* Elevated fasting glucose (≥100 mg/dL);\n* Smoking;\n* Beetroot or watermelon allergy;\n* Unwillingness to avoid beetroot or watermelon products during the entire study;\n* Other chronic diseases (diabetes, liver disease, etc.) or acutely ill'}, 'identificationModule': {'nctId': 'NCT04781595', 'briefTitle': 'Watermelon and Beetroot Products on Endothelial Function', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do Rio de Janeiro'}, 'officialTitle': 'Effect of Watermelon and Beetroot Products on Endothelial Function in Young and Older Adults', 'orgStudyIdInfo': {'id': 'E-26/202.905/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Watermelon', 'description': 'Watermelon powder containing 3 g of L-citrulline.', 'interventionNames': ['Dietary Supplement: Watermelon']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Beetroot', 'description': 'Beetroot powder containing 8 mmol of nitrate.', 'interventionNames': ['Dietary Supplement: Beetroot']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Watermelon + beetroot', 'description': 'Watermelon powder containing 3 g of L-citrulline and Beetroot powder containing 8 mmol of nitrate.', 'interventionNames': ['Dietary Supplement: Watermelon + beetroot']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Maltodextrin', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Watermelon', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A single dose of watermelon powder containing 3g of L-citrulline', 'armGroupLabels': ['Watermelon']}, {'name': 'Beetroot', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A single dose of beetroot powder containing 8 mmol of nitrate', 'armGroupLabels': ['Beetroot']}, {'name': 'Watermelon + beetroot', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A single dose of watermelon and beetroot powder containing 3g of L-citrulline and 8 mmol of nitrate', 'armGroupLabels': ['Watermelon + beetroot']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A single dose of maltodextrin', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27979-000', 'city': 'Macaé', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Universidade Federal do Rio de Janeiro', 'geoPoint': {'lat': -22.38484, 'lon': -41.78324}}], 'overallOfficials': [{'name': 'Thiago Alvares, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Federal do Rio de Janeiro'}]}, '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'}}}}