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Lycopene-rich Juice Intervention to Reduce Inflammatory Markers Among Adults With Obesity

Examining Associations Between Fruit and Vegetable Intake, Skin Carotenoids, and Inflammation Among Racially and Ethnically Diverse Participants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07120035
Enrollment
27
Registered
2025-08-13
Start date
2024-03-27
Completion date
2024-09-16
Last updated
2025-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Markers

Brief summary

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.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTLycopene-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.

Sponsors

Baylor College of Medicine
CollaboratorOTHER
University of Minnesota
CollaboratorOTHER
East Carolina University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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 your food consumption, have height, weight, body fat, and skin tone measured, and have your skin carotenoids measured using the Veggie Meter. * Willing to maintain your usual levels of exercise and diet. * Willing to consume juice daily for the study duration, 3 weeks. We will provide this juice to you.

Exclusion criteria

* Not one of the racial/ethnic groups specified * Under 18 years of age * Not able to speak, read, and understand English * Not willing to drink the test juice daily * Unable to get to the research office for the baseline and follow-up measures

Design outcomes

Primary

MeasureTime frameDescription
Plasma Carotenoids3 weeksµg/dL
Skin Carotenoid Status3 weeksMeasured as skin carotenoid concentrations using the Veggie Meter which uses reflection spectroscopy.
Inflammatory Markers3 weeksMean Fluorescence Intensity (MFI)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026