Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-02-25 @ 6:43 PM
Study NCT ID:
NCT02271633
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2014-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nitrate Supplementation; Source
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C031618', 'term': 'sodium nitrate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-15', 'studyFirstSubmitDate': '2014-10-13', 'studyFirstSubmitQcDate': '2014-10-20', 'lastUpdatePostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Baseline characteristics', 'timeFrame': '1 hour during visit 1 (Screening)', 'description': 'Resting blood pressure, height, body weight, age, BMI'}], 'primaryOutcomes': [{'measure': 'Plasma nitrite levels', 'timeFrame': 'Baseline until 5 hours after ingestion', 'description': 'Plasma nitrite levels following ingestion of dietary nitrate'}], 'secondaryOutcomes': [{'measure': 'Plasma levels of nitrate', 'timeFrame': 'Baseline until 5 hours post-ingestion', 'description': 'Plasma nitrate levels following ingestion of dietary nitrate'}, {'measure': 'Resting blood pressure', 'timeFrame': 'Baseline, 2.5 hours and 5 hours post-ingestion', 'description': 'Resting blood pressure measures following ingestion of dietary nitrate'}, {'measure': 'Tongue scraping to assess bacterial mouth flora.', 'timeFrame': '5 h post-ingestion', 'description': 'Tongue scraping to assess bacterial mouth flora.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nitrate', 'Bioavailability', 'Sports'], 'conditions': ['Blood Pressure', 'Nutritional Physiological Phenomena']}, 'referencesModule': {'references': [{'pmid': '23640589', 'type': 'BACKGROUND', 'citation': 'Wylie LJ, Kelly J, Bailey SJ, Blackwell JR, Skiba PF, Winyard PG, Jeukendrup AE, Vanhatalo A, Jones AM. Beetroot juice and exercise: pharmacodynamic and dose-response relationships. J Appl Physiol (1985). 2013 Aug 1;115(3):325-36. doi: 10.1152/japplphysiol.00372.2013. Epub 2013 May 2.'}, {'pmid': '18723086', 'type': 'BACKGROUND', 'citation': 'van Velzen AG, Sips AJ, Schothorst RC, Lambers AC, Meulenbelt J. The oral bioavailability of nitrate from nitrate-rich vegetables in humans. Toxicol Lett. 2008 Oct 1;181(3):177-81. doi: 10.1016/j.toxlet.2008.07.019. Epub 2008 Aug 3.'}, {'pmid': '22414688', 'type': 'BACKGROUND', 'citation': 'Hobbs DA, Kaffa N, George TW, Methven L, Lovegrove JA. Blood pressure-lowering effects of beetroot juice and novel beetroot-enriched bread products in normotensive male subjects. Br J Nutr. 2012 Dec 14;108(11):2066-74. doi: 10.1017/S0007114512000190. Epub 2012 Mar 14.'}, {'pmid': '24120618', 'type': 'BACKGROUND', 'citation': 'Liu AH, Bondonno CP, Croft KD, Puddey IB, Woodman RJ, Rich L, Ward NC, Vita JA, Hodgson JM. Effects of a nitrate-rich meal on arterial stiffness and blood pressure in healthy volunteers. Nitric Oxide. 2013 Nov 30;35:123-30. doi: 10.1016/j.niox.2013.10.001. Epub 2013 Oct 10.'}, {'pmid': '22248502', 'type': 'BACKGROUND', 'citation': "Cermak NM, Gibala MJ, van Loon LJ. Nitrate supplementation's improvement of 10-km time-trial performance in trained cyclists. Int J Sport Nutr Exerc Metab. 2012 Feb;22(1):64-71. doi: 10.1123/ijsnem.22.1.64."}, {'pmid': '27075914', 'type': 'DERIVED', 'citation': 'Jonvik KL, Nyakayiru J, Pinckaers PJ, Senden JM, van Loon LJ, Verdijk LB. Nitrate-Rich Vegetables Increase Plasma Nitrate and Nitrite Concentrations and Lower Blood Pressure in Healthy Adults. J Nutr. 2016 May;146(5):986-93. doi: 10.3945/jn.116.229807. Epub 2016 Apr 13.'}]}, 'descriptionModule': {'briefSummary': 'The main aim of the current study will be to compare the effects of ingesting different nitrate-rich sources on plasma nitrite concentrations.', 'detailedDescription': 'Oral ingestion of nitrate (NO3-) has been shown to increase plasma nitrate and nitrite levels. Significant lowering of pulmonary oxygen uptake during exercise, as well as significantly lower blood pressure values at rest have been observed after supplementation with nitrate. However, no study has yet described a direct comparison between different nitrate-rich beverages with respect to the bioavailability of nitrate/nitrite and the possible hemodynamic effects. Based on the gaps in current literature, our main goal will therefore be to gain further insight into the effects of nitrate supplementation with different sources on plasma nitrite levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18.5 \\< BMI \\< 30 kg/m2\n* Engagement in regular physical activity ( \\> 1 h a week)\n\nExclusion Criteria:\n\n* Use of medication\n* Smoking\n* Currently supplementing diet with nitrate\n* Lactose intolerance'}, 'identificationModule': {'nctId': 'NCT02271633', 'acronym': 'NO-what', 'briefTitle': 'Nitrate Supplementation; Source', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'The Effect of Nitrate Supplementation: Source of Supplementation', 'orgStudyIdInfo': {'id': 'METC14-3-020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sodium nitrate', 'description': 'Dietary supplement: 800 mg of nitrate in sodium nitrate added with water to get a 140 mL solution (BASF, Ludwigshafen, Germany)', 'interventionNames': ['Dietary Supplement: Beetroot juice', 'Dietary Supplement: Spinach', 'Dietary Supplement: Rocket salad']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Beetroot juice', 'description': 'Dietary supplement: 800 mg of nitrate in concentrated beetroot juice (Beet-IT)', 'interventionNames': ['Dietary Supplement: Sodium nitrate', 'Dietary Supplement: Spinach', 'Dietary Supplement: Rocket salad']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Spinach', 'description': 'Dietary supplement: 800 mg of nitrate in a spinach based beverage', 'interventionNames': ['Dietary Supplement: Sodium nitrate', 'Dietary Supplement: Beetroot juice', 'Dietary Supplement: Rocket salad']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rocket salad', 'description': 'Dietary supplement: 800 mg of nitrate in a rocket salad based beverage', 'interventionNames': ['Dietary Supplement: Sodium nitrate', 'Dietary Supplement: Beetroot juice', 'Dietary Supplement: Spinach']}], 'interventions': [{'name': 'Sodium nitrate', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Beetroot juice', 'Rocket salad', 'Spinach']}, {'name': 'Beetroot juice', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Rocket salad', 'Sodium nitrate', 'Spinach']}, {'name': 'Spinach', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Beetroot juice', 'Rocket salad', 'Sodium nitrate']}, {'name': 'Rocket salad', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Beetroot juice', 'Sodium nitrate', 'Spinach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6200MD', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Centre+', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Lex Verdijk, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}