Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2026-01-01 @ 5:27 PM
Study NCT ID:
NCT07120035
Status:
COMPLETED
Last Update Posted:
2025-08-13
First Post:
2025-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lycopene-rich Juice Intervention to Reduce Inflammatory Markers Among Adults With Obesity
Sponsor:
East Carolina University
Organization:
Study Overview
Official Title:
Examining Associations Between Fruit and Vegetable Intake, Skin Carotenoids, and Inflammation Among Racially and Ethnically Diverse Participants
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: