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Examining Validity and Sensitivity of Pressure-Mediated Reflection Spectroscopy

NCT04056624 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2023-06-15

Study results available
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Summary

The central goal of this proposal is to examine validity and sensitivity of RS-assessed skin carotenoid status as a marker of F\&V intake in a racially and ethnically diverse sample of individuals. First, investigators will examine the association (RS Device Validity) between RS-assessed skin carotenoids and the primary outcomes of objectively-measured plasma carotenoids and self-reported F\&V consumption across four diverse groups: African-American/Black, Asian, White, and Hispanic/Latino (n=213). Then the investigators will conduct a randomized controlled trial to define the relative skin carotenoid responses (RS Device Sensitivity) across racial-ethnic groups, in comparison with plasma carotenoid responses. The investigators will conduct a 6-week randomized controlled trial of a carotenoid-containing juice intervention \[placebo control, low and high dose juice (N=156). Finally, the genetic basis for racial/ethnic group differences in skin carotenoid responses to diet will be investigated through hypothesis-driven genomic analysis of participants from Aims 1 and 2.

Conditions

  • Dietary Habits
  • Diet, Healthy

Interventions

DIETARY_SUPPLEMENT

High carotenoid juice

Juice with high carotenoids

DIETARY_SUPPLEMENT

Placebo control - Apple juice

Juice with negligible carotenoids

Sponsors & Collaborators

  • University of Minnesota

    collaborator OTHER

  • Baylor College of Medicine

    collaborator OTHER

  • East Carolina University

    lead OTHER

Principal Investigators

  • Stephanie B Jilcott Pitts, PhD · East Carolina University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-28
Primary Completion
2022-04-14
Completion
2022-04-14

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04056624 on ClinicalTrials.gov