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

U

University of North Carolina System

Status

Completed

Conditions

Inflammatory Markers

Treatments

Dietary Supplement: Lycopene-rich juice

Study type

Interventional

Funder types

Other

Identifiers

NCT07120035
UMCIRB 23-002535

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

27 participants in 1 patient group

Lycopene-rich juice group
Experimental group
Treatment:
Dietary Supplement: Lycopene-rich juice

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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