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

Not Applicable

Completed

• Conditions: Inflammatory Markers

• Registration Number: NCT07120035
• Lead Sponsor: East Carolina University

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.

Study Timeline

• Study Start: 2024-03-27
• Primary Completion: 2024-09-16
• Study Completion: 2024-09-16
• Status Verified: 2025-08
• Study First Submitted: 2025-08-01
• Study First Submitted QC: 2025-08-08
• Last Update Submitted: 2025-08-08
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Plasma Carotenoids	3 weeks	µg/dL
Skin Carotenoid Status	3 weeks	Measured as skin carotenoid concentrations using the Veggie Meter which uses reflection spectroscopy.
Inflammatory Markers	3 weeks	Mean Fluorescence Intensity (MFI)

Trial Locations

Locations (1)

East Carolina Diabetes and Obesity Institute; 🇺🇸 Greenville, North Carolina, United States