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

NCT07120035 | Completed

• 1 other identifier: UMCIRB 23-002535
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Markers

Outcome Measures

Primary Outcomes (3)

• Plasma Carotenoids

  µg/dL

  3 weeks

• Skin Carotenoid Status

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

  3 weeks

• Inflammatory Markers

  Mean Fluorescence Intensity (MFI)

  3 weeks

Study Arms (1)

Lycopene-rich juice group

EXPERIMENTAL

Dietary Supplement: Lycopene-rich juice

Interventions

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.

Lycopene-rich juice group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• East Carolina University: lead
• Baylor College of Medicine: collaborator
• University of Minnesota: collaborator

Study Sites (1)

East Carolina Diabetes and Obesity Institute

Greenville, North Carolina, 27834, United States

Location

Study Officials

• Stephanie Pitts, PhD

  East Carolina University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 13, 2025
• Study Start: March 27, 2024
• Primary Completion: September 16, 2024
• Study Completion: September 16, 2024
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The IPD will be available to other researchers whenever they have completed ethics board (IRB) approval from their home institution.

Locations

US (1)