Inflammatory MarkersNCT07120035
Lycopene-rich Juice Intervention to Reduce Inflammatory Markers Among Adults With Obesity
A study testing Lycopene-rich juice in people with Inflammatory Markers, run by East Carolina University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Markers
- What is being tested?
- Lycopene-rich juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2024to 16 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
East Carolina Diabetes and Obesity Institute
Greenville, North Carolina, 27834
About this study
Official title: Examining Associations Between Fruit and Vegetable Intake, Skin Carotenoids, and Inflammation Among Racially and Ethnically Diverse Participants
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.
Read the 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.
- Conditions
- Inflammatory Markers
- Being tested
- Lycopene-rich juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lycopene-rich juiceDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Lycopene-rich juice group | Experimental | Not described Receives: Dietary Supplement: Lycopene-rich juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Carotenoids
µg/dL
Measured: 3 weeks
Skin Carotenoid Status
Measured as skin carotenoid concentrations using the Veggie Meter which uses reflection spectroscopy.
Measured: 3 weeks
Inflammatory Markers
Mean Fluorescence Intensity (MFI)
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start27 Mar 2024
- Primary completion16 Sep 2024
- Study completion16 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory MarkersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine, University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Stephanie Pitts, PhD, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120035
- Sponsor's protocol ID
- UMCIRB 23-002535
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share participant data with other researchers as long as they have institutional review board approval.
Publications
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.
PubMed 41420244
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Associations Between Fruit and Vegetable Intake, Skin Carotenoids, and Inflammation Among Racially and Ethnically Diverse Participants
- ClinicalTrials.gov ID
- NCT07120035
- Acronym / sponsor ID
- UMCIRB 23-002535
- Conditions
- Inflammatory Markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Collaborators
- Baylor College of Medicine, University of Minnesota
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 16 Sep 2024 (actual)
- Study completion
- 16 Sep 2024 (actual)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lycopene-rich juice group | Experimental | Dietary Supplement: Lycopene-rich juice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lycopene-rich juiceWe 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. | Dietary supplement | Lycopene-rich juice group |
Primary outcome
Plasma Carotenoids
Time frame: 3 weeks
µg/dL
Skin Carotenoid Status
Time frame: 3 weeks
Measured as skin carotenoid concentrations using the Veggie Meter which uses reflection spectroscopy.
Inflammatory Markers
Time frame: 3 weeks
Mean Fluorescence Intensity (MFI)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Derived from this study: PubMed 41420244Jilcott 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.
- Individual participant dataSharing planned: Yes. We will share participant data with other researchers as long as they have institutional review board approval.
Related trials for Inflammatory Markers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Pitts, PhD principal investigator
East Carolina University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lycopene-rich juice in people with Inflammatory Markers, run by East Carolina University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Carotenoids (time frame: 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07120035, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.