Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2026-01-01 @ 5:27 PM
Study NCT ID:
NCT07120035
Status:
COMPLETED
Last Update Posted:
2025-08-13
First Post:
2025-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lycopene-rich Juice Intervention to Reduce Inflammatory Markers Among Adults With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2025-08-01', 'studyFirstSubmitQcDate': '2025-08-08', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Carotenoids', 'timeFrame': '3 weeks', 'description': 'µg/dL'}, {'measure': 'Skin Carotenoid Status', 'timeFrame': '3 weeks', 'description': 'Measured as skin carotenoid concentrations using the Veggie Meter which uses reflection spectroscopy.'}, {'measure': 'Inflammatory Markers', 'timeFrame': '3 weeks', 'description': 'Mean Fluorescence Intensity (MFI)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Markers']}, 'referencesModule': {'references': [{'pmid': '41420244', 'type': 'DERIVED', 'citation': 'Jilcott Pitts SB, Wu Q, Laska MN, Gates E, Seese MH, Senkus KE, Carrero Longlax S, Portillo-Varela A, DiNardo AR, Moran NE. Daily intake of a lycopene-rich juice is associated with reductions in inflammatory markers but not increases in skin carotenoids in a pilot study among participants with obesity. BMC Nutr. 2025 Dec 19. doi: 10.1186/s40795-025-01222-y. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this research is to see whether a finger scanning device can accurately measure carotenoids, the colorful substances in fruits and vegetables, in people's skin. Participants are being invited to take part in this research because they are over the age of 18 years, and a healthy volunteer. To be eligible, participants must be: Non-Hispanic African American/Black, Asian, non-Hispanic White, or Hispanic/Latinx; Over 18 years of age; Able to speak, read, and understand English; Willing and able to drive to the research office, have a small amount of blood drawn by a trained phlebotomist, complete a questionnaire about health, demographics, and food consumption, have height, weight, body fat, and skin tone measured, and have skin carotenoids measured using the Veggie Meter; Willing to maintain usual levels of exercise and diet; Willing to consume juice daily for the study duration, 3 weeks. The juice will be provided to participants.", 'detailedDescription': 'Participants will be asked to drink a lycopene-rich (tomato-based) juice daily for three weeks. At each of 2 clinic visits, participants will be asked to: Fast for 10 hours before coming to the visit; BMI verification; blood draw by a trained phlebotomist to assess the carotenoids in blood and compare those with the carotenoids in skin and self-reported diet; Have weight, height, and body fat percentage measured; Have skin carotenoids measured using the Veggie Meter and skin color/melanin index measured using a skin spectrophotometer. This involves surface coloration scans of the finger and forearm; Complete demographic and diet history questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-Hispanic African American/Black, Asian, non-Hispanic White, or Hispanic/Latinx\n* Over 18 years of age\n* Able to speak, read, and understand English\n* Willing and able to drive to the research office, have a small amount of blood drawn by a trained phlebotomist, complete a questionnaire about health, demographics, and your food consumption, have height, weight, body fat, and skin tone measured, and have your skin carotenoids measured using the Veggie Meter.\n* Willing to maintain your usual levels of exercise and diet.\n* Willing to consume juice daily for the study duration, 3 weeks. We will provide this juice to you.\n\nExclusion Criteria:\n\n* Not one of the racial/ethnic groups specified\n* Under 18 years of age\n* Not able to speak, read, and understand English\n* Not willing to drink the test juice daily\n* Unable to get to the research office for the baseline and follow-up measures'}, 'identificationModule': {'nctId': 'NCT07120035', 'briefTitle': 'Lycopene-rich Juice Intervention to Reduce Inflammatory Markers Among Adults With Obesity', 'organization': {'class': 'OTHER', 'fullName': 'East Carolina University'}, 'officialTitle': 'Examining Associations Between Fruit and Vegetable Intake, Skin Carotenoids, and Inflammation Among Racially and Ethnically Diverse Participants', 'orgStudyIdInfo': {'id': 'UMCIRB 23-002535'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lycopene-rich juice group', 'interventionNames': ['Dietary Supplement: Lycopene-rich juice']}], 'interventions': [{'name': 'Lycopene-rich juice', 'type': 'DIETARY_SUPPLEMENT', 'description': 'We sought to deliver 8400 µg of lycopene per day, and so participants were asked to drink approximately 4 fluid ounces per day of the tomato-based, lycopene-rich juice.', 'armGroupLabels': ['Lycopene-rich juice group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'East Carolina Diabetes and Obesity Institute', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}], 'overallOfficials': [{'name': 'Stephanie Pitts, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'East Carolina University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'The IPD will be available to other researchers whenever they have completed ethics board (IRB) approval from their home institution.', 'ipdSharing': 'YES', 'description': 'We will share participant data with other researchers as long as they have institutional review board approval.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'East Carolina University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baylor College of Medicine', 'class': 'OTHER'}, {'name': 'University of Minnesota', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}