Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT01821820
Status:
COMPLETED
Last Update Posted:
2015-02-02
First Post:
2013-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pistachios, Performance, Metabolomics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D007154', 'term': 'Immune System Diseases'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-30', 'studyFirstSubmitDate': '2013-03-27', 'studyFirstSubmitQcDate': '2013-03-29', 'lastUpdatePostDateStruct': {'date': '2015-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shifts in metabolites (metabolomics)', 'timeFrame': '14-day period', 'description': 'Shifts in metabolites pre-and post-14-days supplementation, and then after 75-km cycling, and the next morning.'}], 'secondaryOutcomes': [{'measure': 'Inflammation', 'timeFrame': '14-day period', 'description': 'Pre- and post-14 d supplementation, and following 75-km cycling; plasma IL-6, IL-8, IL-10, TNF-alpha, G-CSF, MCP-1; C-reactive protein'}, {'measure': 'Immune Function', 'timeFrame': '14-day period', 'description': 'Pre- and post-14 days supplementation, and following 75-km cycling; granulocyte and monocyte phagocytosis and oxidative burst activity; leukoycte differential'}, {'measure': 'Oxidative Stress', 'timeFrame': '14-day period', 'description': 'Pre- and post-14 days supplementation, and following 75-km cycling; RBC glutathione, protein carbonyls, ORAC, FRAP, F2-isoprostanes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Inflammation', 'Oxidative stress', 'Immune dysfunction', 'Metabolites'], 'conditions': ['Inflammation', 'Oxidative Stress', 'Immune Dysfunction']}, 'referencesModule': {'references': [{'pmid': '22458696', 'type': 'BACKGROUND', 'citation': 'Dreher ML. Pistachio nuts: composition and potential health benefits. Nutr Rev. 2012 Apr;70(4):234-40. doi: 10.1111/j.1753-4887.2011.00467.x.'}, {'pmid': '25409020', 'type': 'DERIVED', 'citation': 'Nieman DC, Scherr J, Luo B, Meaney MP, Dreau D, Sha W, Dew DA, Henson DA, Pappan KL. Influence of pistachios on performance and exercise-induced inflammation, oxidative stress, immune dysfunction, and metabolite shifts in cyclists: a randomized, crossover trial. PLoS One. 2014 Nov 19;9(11):e113725. doi: 10.1371/journal.pone.0113725. eCollection 2014.'}], 'seeAlsoLinks': [{'url': 'http://www.ncrc.appstate.edu', 'label': 'Lab web site'}]}, 'descriptionModule': {'briefSummary': 'Ingestion of 3 ounces of pistachio nuts per day for two weeks before and the day of cycling intensely for 75 kilometers will support substrate utilization during exercise (as determined through metabolomics) and improve performance compared to water only, and attenuate inflammation, oxidative stress, and immune dysfunction during 24 hours of recovery.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male endurance cyclists\n* Capable of exercising for 2.5 h at a high intensity in the lab\n* Ages 18-55\n* Agree to train normally and stay weight stable.\n* Agree to avoid the use of large dose vitamin/mineral supplements\n* Agree to avoid herbs and medications that influence inflammation\n\nExclusion Criteria:\n\n* Regularly take supplements or medicines known to effect inflammation.\n* At moderate or high risk for cardiovascular disease.\n* Younger than 18 or older than 55 years of age.\n* No history of competing in cycling races.'}, 'identificationModule': {'nctId': 'NCT01821820', 'briefTitle': 'Pistachios, Performance, Metabolomics', 'organization': {'class': 'OTHER', 'fullName': 'Appalachian State University'}, 'officialTitle': 'Influence of Pistachios on Performance and Exercise-induced Inflammation, Oxidative Stress, and Immune Dysfunction in Athletes: a Metabolomics-based Approach.', 'orgStudyIdInfo': {'id': '13-0064'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pistachios', 'description': 'Pistachio treatment (3 oz/d) for two weeks; 3 oz pistachio nuts and water (1.5 oz. before, and 1.5 oz during) cycling 75 km.', 'interventionNames': ['Other: Pistachios']}, {'type': 'NO_INTERVENTION', 'label': 'No pistachios', 'description': 'No pistachios for two weeks, or before and during 75 km cycling.'}], 'interventions': [{'name': 'Pistachios', 'type': 'OTHER', 'armGroupLabels': ['Pistachios']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28787', 'city': 'Kannapolis', 'state': 'North Carolina', 'country': 'United States', 'facility': 'ASU Human Performance Laboratory, North Carolina Research Campus', 'geoPoint': {'lat': 35.48736, 'lon': -80.62173}}], 'overallOfficials': [{'name': 'David C. Nieman, DrPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Appalachian State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Appalachian State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Pistachio Growers', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}