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Completed

NCT Number: NCT07120035

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

East Carolina Diabetes and Obesity Institute

Greenville, North Carolina, 27834, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lycopene-rich juice

Dietary Supplement

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.

Primary outcomes

  1. Plasma Carotenoids

    Time frame: 3 weeks

    µg/dL

  2. Skin Carotenoid Status

    Time frame: 3 weeks

    Measured as skin carotenoid concentrations using the Veggie Meter which uses reflection spectroscopy.

  3. Inflammatory Markers

    Time frame: 3 weeks

    Mean Fluorescence Intensity (MFI)

Sponsors and collaborators

Lead sponsor

East Carolina University

Other

Collaborators

  • Baylor College of Medicine
  • University of Minnesota

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 13, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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