Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2026-01-24 @ 4:14 AM
Study NCT ID:
NCT02346812
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2015-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brassica Intake and Isothiocyanate Absorption
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-29', 'studyFirstSubmitDate': '2015-01-15', 'studyFirstSubmitQcDate': '2015-01-20', 'lastUpdatePostDateStruct': {'date': '2015-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total isothiocyanates (ITC)', 'timeFrame': '24-hr', 'description': 'At the end of each study period, total ITC equivalents will be measured in blood and urine over a 24-hour period.'}], 'secondaryOutcomes': [{'measure': 'Fecal microbiota', 'timeFrame': 'End of 3-week study period', 'description': 'Fecal microbiota will be measured at the end of each 3-week study period.'}, {'measure': 'Gastrointestinal health', 'timeFrame': '8-hr', 'description': 'At the end of each 3-week study period, urine will be collected for 8 hours as part of the lactulose-mannitol test, which is a measure of gastrointestinal health.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '30499426', 'type': 'DERIVED', 'citation': 'Charron CS, Vinyard BT, Ross SA, Seifried HE, Jeffery EH, Novotny JA. Absorption and metabolism of isothiocyanates formed from broccoli glucosinolates: effects of BMI and daily consumption in a randomised clinical trial. Br J Nutr. 2018 Dec;120(12):1370-1379. doi: 10.1017/S0007114518002921.'}]}, 'descriptionModule': {'briefSummary': 'Healthy individuals (n=18) will participate in 2 controlled-feeding study periods that are 3 weeks each in length: 1) Control diet 2) Brassica diet. The control diet will consist of typical American foods and will be free of Brassica vegetables and free of glucosinolates and isothiocyanates. The Brassica diet will contain the control diet plus glucosinolate/isothiocyanate treatment foods. There will be a break of 3 weeks in between study periods. Blood, urine, and fecal samples will be collected at the end of each study period. Eligible participants will be selected based on genotype for glutathione S-transferase (GST), which has been shown to influence the potential protective role of dietary Brassicas. Half the participants (n=9) will be GSTM1-positive individuals and half (n=9) will have the GSTM1-null genotype.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 21 - 70 years of age\n* Not currently taking glucosinolate/ITC containing supplements\n* Voluntarily agree to participate and sign an informed consent document\n* Free of cancer (never diagnosed or cancer-free for at least 5 y)\n\nExclusion Criteria:\n\n* Pregnant, lactating, or intend to become pregnant during the study period\n* Known allergy or intolerance to Brassica vegetables\n* History of bariatric surgery or nutrient malabsorption disease (such as celiac disease) or other metabolic disorders requiring special diet recommendations\n* Use of tobacco products\n* Use of certain medications (prescription or over-the-counter) that may interfere with the study objectives\n* Type 2 diabetes requiring the use of diabetes pills, insulin, or non-insulin shots\n* Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol, or Miradon (anisindione)\n* Unable or unwilling to give informed consent or communicate with study staff\n* Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)\n* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol'}, 'identificationModule': {'nctId': 'NCT02346812', 'briefTitle': 'Brassica Intake and Isothiocyanate Absorption', 'organization': {'class': 'FED', 'fullName': 'USDA Beltsville Human Nutrition Research Center'}, 'officialTitle': 'Brassica Intake and Isothiocyanate Absorption: Intake Patterns May Have Implications for Cancer Prevention by Dietary Brassica Vegetables', 'orgStudyIdInfo': {'id': 'HS49'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brassica', 'description': 'Brassica vegetables will be consumed daily as part of a controlled diet.', 'interventionNames': ['Other: Controlled diet with brassica vegetables']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Typical American diet will be consumed, without any Brassica vegetables.', 'interventionNames': ['Other: Controlled diet without brassica vegetables']}], 'interventions': [{'name': 'Controlled diet without brassica vegetables', 'type': 'OTHER', 'description': 'Participants will be fed a controlled diet containing foods of a typical American diet.', 'armGroupLabels': ['Control']}, {'name': 'Controlled diet with brassica vegetables', 'type': 'OTHER', 'description': 'Participants will be fed a controlled diet containing foods of a typical American diet.', 'armGroupLabels': ['Brassica']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20705', 'city': 'Beltsville', 'state': 'Maryland', 'country': 'United States', 'facility': 'US Department of Agriculture Beltsville Human Nutrition Research Center', 'geoPoint': {'lat': 39.03483, 'lon': -76.90747}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'USDA Beltsville Human Nutrition Research Center', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Physiologist', 'investigatorFullName': 'Janet Novotny', 'investigatorAffiliation': 'USDA Beltsville Human Nutrition Research Center'}}}}