Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-01-24 @ 1:23 AM
Study NCT ID:
NCT02115893
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2014-04-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nitrate Supplementation; Duration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C031618', 'term': 'sodium nitrate'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-15', 'studyFirstSubmitDate': '2014-04-10', 'studyFirstSubmitQcDate': '2014-04-14', 'lastUpdatePostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Baseline characteristics and fitness level assessment', 'timeFrame': '3 hours during visit 1 (Screening)', 'description': 'Resting blood pressure, height, body weight, age, BMI, measures of GI tolerance, VO2 max, Wmax, rate of perceived exertion'}], 'primaryOutcomes': [{'measure': 'Time-trial exercise performance', 'timeFrame': "Time trial starts 4 hours after ingestion and ends on average after 15 minutes of cycling (depending on subject's cycling speed)", 'description': 'The primary outcome measure will be the time to complete the time-trial following dietary nitrate or placebo ingestion'}], 'secondaryOutcomes': [{'measure': 'Resting blood pressure', 'timeFrame': '30 min pre-ingestion until 2.5 hours post-ingestion', 'description': 'Resting blood pressure measures following ingestion of dietary nitrate'}, {'measure': 'Plasma nitrate and nitrite levels', 'timeFrame': '30 min pre-ingestion until 30 min post-time-trial testing', 'description': 'Plasma nitrate and nitrite levels following ingestion of dietary nitrate'}, {'measure': 'Submaximal exercise performance', 'timeFrame': 'starting from 3 hours post-ingestion on testing days until completion of the submaximal exercise', 'description': 'Oxygen consumption CO2 production and heart rate during submaximal exercise'}, {'measure': 'Time-trial exercise performance; power output and heart rate', 'timeFrame': 'starting from 4 hours post-ingestion on testing days until completion of the time-trial', 'description': 'Power output and heart rate during the time-trial exercise'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nitrate', 'Performance', 'Sports'], 'conditions': ['Time-trial Performance', 'Submaximal Exercise Performance', 'Nitrite', 'Nitrate']}, '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': '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': '22260513', 'type': 'BACKGROUND', 'citation': 'Bescos R, Sureda A, Tur JA, Pons A. The effect of nitric-oxide-related supplements on human performance. Sports Med. 2012 Feb 1;42(2):99-117. doi: 10.2165/11596860-000000000-00000.'}]}, 'descriptionModule': {'briefSummary': 'The main aim of the current study will be to find the optimal duration of supplementation to enhance sports performance.', 'detailedDescription': 'Oral ingestion of nitrate (NO3-) in the form of both nitrate salts and beetroot juice has been shown to significantly lower blood pressure at rest and to also lower pulmonary oxygen uptake during exercise, in addition to improving exercise performance during cycle time trial. However, there has been no consensus on the optimal supplementation protocols, in terms of duration of supplementation to see these metabolic effects. Furthermore, a positive exercise performance effect of nitrate ingestion has primarily been observed in recreational athletes. The potentially ergogenic effects of nitrate in well-trained or elite athletes therefore remain to be fully established. Based on the gaps in current literature, our main goal will be to gain further insight into different aspects of nitrate supplementation to enhance (elite) sports performance. This will be investigated in this study by assessing the effect of an acute vs. chronic supplementation period of sodium nitrate (NaNO3-) on exercise performance.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18.5 \\< BMI \\< 25 kg/m2\n* Endurance trained cyclists/triathletes (with at least 1 year of competitive cycling experience)\n* VO2max ≥ 55 mL/kg/min\n\nExclusion Criteria:\n\n* Use of medication\n* Injury prohibiting them from performing the exercise protocol effectively\n* Smoking\n* Currently supplementing diet with nitrate\n* Lactose intolerance'}, 'identificationModule': {'nctId': 'NCT02115893', 'acronym': 'NO-how', 'briefTitle': 'Nitrate Supplementation; Duration', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'The Effect of Nitrate Supplementation on Sports Performance: Duration of Supplementation', 'orgStudyIdInfo': {'id': 'METC13-3-059'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sodium Nitrate', 'description': 'Dietary Supplement: Sodium nitrate 800 mg of nitrate in sodium nitrate added with water to get a 140 mL solution (BASF, Ludwigshafen, Germany)', 'interventionNames': ['Dietary Supplement: Sodium Nitrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sodium Cloride', 'description': 'Dietary Supplement: Sodium chloride 800 mg of sodium chloride added with water to get a 140 mL solution (Frisia Zout BV, Harlingen, The Netherlands)', 'interventionNames': ['Dietary Supplement: Sodium Chloride']}], 'interventions': [{'name': 'Sodium Nitrate', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Sodium Nitrate']}, {'name': 'Sodium Chloride', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Sodium Cloride']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6200 MD', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Centre+', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '6200MD', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Centre+', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Lex B Verdijk, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}