Lycopene-rich Juice Intervention to Reduce Inflammatory M... | NCT07120035

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

NCT07120035

Sponsor

East Carolina University

Status

Completed

Last Update Posted

Aug 13, 2025Actual

Enrollment

27Actual

Phase

Not Applicable

Conditions

Inflammatory Markers

Interventions

Lycopene-rich juice

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 27, 2024Actual

Primary Completion Date

Sep 16, 2024Actual

Completion Date

Sep 16, 2024Actual

First Submitted Date

Aug 1, 2025

First Submission Date that Met QC Criteria

Aug 8, 2025

First Posted Date

Aug 13, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2025

Last Update Posted Date

Aug 13, 2025Actual

Name	Class
Baylor College of Medicine	OTHER
University of Minnesota	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lycopene-rich juice group	Experimental		Dietary Supplement: Lycopene-rich juice

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephanie Pitts, PhD	East Carolina University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
East Carolina Diabetes and Obesity Institute		Greenville	North Carolina	27834	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41420244	Derived	Jilcott Pitts SB, Wu Q, Laska MN, Gates E, Seese MH, Senkus KE, Carrero Longlax S, Portillo-Varela A, DiNardo AR, Moran NE. Daily intake of a lycopene-rich juice is associated with reductions in inflammatory markers but not increases in skin carotenoids in a pilot study among participants with obesity. BMC Nutr. 2025 Dec 19;12(1):11. doi: 10.1186/s40795-025-01222-y.