An interventional study of Lycopene-rich juice in Inflammatory Markers, sponsored by East Carolina University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-13.
Sponsored by East Carolina University · Not applicable, Interventional, and Other
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.
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.
East Carolina University is the lead sponsor of 83 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dietary Supplement: Lycopene-rich juice
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.
Plasma Carotenoids
µg/dL
Time frame: 3 weeks
Skin Carotenoid Status
Measured as skin carotenoid concentrations using the Veggie Meter which uses reflection spectroscopy.
Time frame: 3 weeks
Inflammatory Markers
Mean Fluorescence Intensity (MFI)
Time frame: 3 weeks
Plan to share: Yes — We will share participant data with other researchers as long as they have institutional review board approval.
Supporting information: Study protocol, Sap, Icf, Analytic code
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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East Carolina University