Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-01-07 @ 7:55 AM
Study NCT ID:
NCT00636350
Status:
COMPLETED
Last Update Posted:
2017-10-12
First Post:
2008-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability of Pepper Carotenoids in Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014975', 'term': 'Lutein'}], 'ancestors': [{'id': 'D024341', 'term': 'Xanthophylls'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2010-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-11', 'studyFirstSubmitDate': '2008-03-07', 'studyFirstSubmitQcDate': '2008-03-13', 'lastUpdatePostDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The enrichment of labeled pepper carotenoids in the serum samples after the meals.', 'timeFrame': 'upto 21 days after the start of the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pepper carotenoids', 'xanthophylls', 'healthy volunteers'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '\\- list item one, Peppers\n\nWe propose to evaluate bio absorption of pepper carotenoids in a red bell-pepper or non-pungent green jalapeno pepper. The pepper will be provided in a cooked dish. The specific aims of this study are: 1) to determine blood response kinetics of lutein following multiple doses of non-pungent green jalapeno pepper with meals. 2) to determine blood response kinetics of zeaxanthin/capsanthin following multiple doses of red bell pepper with meals. We will feed 16 healthy man and women (50 - 65 y, females were at least one year post menopause), each cooked green jalapeno pepper or red pepper for 4 days and donate blood samples up to 21 days to determine blood response kinetics of xanthophylls following multiple doses of pepper dishes.', 'detailedDescription': '\\- list item one, Peppers\n\nEpidemiological data show that carotenoids and ß-C are health promoting when taken at physiologic levels in foods. However, human absorption and metabolism of carotenoids contained in various food matrices has not been studied well. It is important to investigate the characteristics of absorption and disposal kinetics after eating carotenoid rich foods in order to gain a basic understanding of the biological characteristics of lutein, zeaxanthin, and other carotenoids in food sources.\n\nWe propose to evaluate bio absorption of pepper carotenoids in a 2-phase research study: phase 1 will utilize red bell-pepper and phase 2 will utilize non-pungent green jalapeno pepper. The pepper will be provided as a dish in a meal. We will feed 16 healthy man and women (50 - 70 y, females were at least one year post menopause), each with red pepper (phase 1) and/or green jalapeno pepper (phase 2) for \\~ 4 days and donate blood samples up to 21 days. Volunteers will be randomly assigned to one of the following two phases: phase 1 and phase 2.\n\nThe study will provide us the information on the bioavailability of pepper carotenoids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteers\n\nExclusion Criteria:\n\n* GI track problems'}, 'identificationModule': {'nctId': 'NCT00636350', 'briefTitle': 'Bioavailability of Pepper Carotenoids in Humans', 'organization': {'class': 'OTHER', 'fullName': 'Tufts University'}, 'orgStudyIdInfo': {'id': '58-1950-7-707'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pepper', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['lutein', 'xanthaphylls'], 'description': 'pepper carotenoids as meals'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts University', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Guangwen Tang', 'oldOrganization': 'Tufts University'}}}}