Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-01-02 @ 12:15 AM
Study NCT ID:
NCT05004935
Status:
UNKNOWN
Last Update Posted:
2023-11-15
First Post:
2021-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Beetroot Juice on Plasma Trimethylamine N-oxide Concentration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-12-13', 'releaseDate': '2024-11-05'}], 'estimatedResultsFirstSubmitDate': '2024-11-05'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009566', 'term': 'Nitrates'}], 'ancestors': [{'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017942', 'term': 'Nitric Acid'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-14', 'studyFirstSubmitDate': '2021-08-05', 'studyFirstSubmitQcDate': '2021-08-11', 'lastUpdatePostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of beetroot juice consumption on plasma trimethylamine N-oxide concentration', 'timeFrame': '4 hours', 'description': 'Determination of plasma trimethylamine N-oxide concentration following the beetroot juice consumption using ultra performance liquid chromatography - tandem mass spectrometer (UPLC-MS/MS) method.'}], 'secondaryOutcomes': [{'measure': 'The effect of circulating trimethylamine N-oxide modification on plasma total antioxidant status', 'timeFrame': '4 hours', 'description': 'Determination of plasma total antioxidant status following the beetroot juice consumption using commercially available kit.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '38110180', 'type': 'DERIVED', 'citation': 'Jurga J, Samborowska E, Zielinski J, Olek RA. Effects of Acute Beetroot Juice and Sodium Nitrate on Selected Blood Metabolites and Response to Transient Ischemia: A Crossover Randomized Clinical Trial. J Nutr. 2024 Feb;154(2):491-497. doi: 10.1016/j.tjnut.2023.12.018. Epub 2023 Dec 16.'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of the current study is to determine the effect of beetroot juice consumption on plasma trimethylamine N-oxide concentration.\n\nA secondary aims: exploring the effect of circulating trimethylamine N-oxide modification on plasma total antioxidant status, and measurement of changes in the skin nicotinamide-adenine dinucleotide reduced form (NADH) content during transient ischemia and reperfusion.', 'detailedDescription': 'In a random order subjects will consume beetroot juice (140ml), or equimolar nitrates (NaNO3). Antecubital vein blood samples will be taken at the beginning, and every hour for 4 hours following consumption.\n\nPlasma trimethylamine N-oxide, total antioxidant status, and nitrite/nitrate concentrations will be determined.\n\nUsing Flow Mediated Skin Fluorescence skin NADH content determined during controlled ischemia triggered by total occlusion of the brachial artery by the brachial blood pressure cuff and during reperfusion after deflation of the blood pressure cuff 2 and 4 hours following consumption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nhealthy volunteers\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT05004935', 'acronym': 'BRJ_TMAO', 'briefTitle': 'The Effect of Beetroot Juice on Plasma Trimethylamine N-oxide Concentration', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Physical Education'}, 'officialTitle': 'Analysis of Electromyography Activation Trunk Muscles and the Effect of Beetroot Juice Intake on the Results in Strength Exercises: Lateral Medicine Ball Throw and Sled Pushing', 'orgStudyIdInfo': {'id': 'RMPN2021/JJ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'beetroot juice', 'description': 'single intake of beetroot juice containing 800mg nitrates', 'interventionNames': ['Dietary Supplement: beetroot juice']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'nitrates', 'description': 'single intake of 800mg nitrates (NaNO3)', 'interventionNames': ['Other: nitrate']}], 'interventions': [{'name': 'beetroot juice', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['140 ml of Beet It juice'], 'description': 'single intake of beetroot juice containing 800mg nitrates', 'armGroupLabels': ['beetroot juice']}, {'name': 'nitrate', 'type': 'OTHER', 'otherNames': ['NaNO3'], 'description': 'single intake of 800mg nitrates', 'armGroupLabels': ['nitrates']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61-871', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Akademia Wychowania Fizycznego', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'overallOfficials': [{'name': 'Robert A Olek, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Poznan University of Physical Education'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Physical Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Robert Olek', 'investigatorAffiliation': 'Poznan University of Physical Education'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-11-05', 'type': 'RELEASE'}, {'date': '2024-12-13', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Robert Olek, Principal Investigator, Poznan University of Physical Education'}}}}