CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 162 enrolled
Drug / intervention
High carotenoid juice +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04056624
NCT04056624N/ACompleted

Examining Validity and Sensitivity of Pressure-Mediated Reflection Spectroscopy as a Measure of Fruit and Vegetable Consumption in a Diverse Community

East Carolina University·interventional·Posted Aug 14, 2019·Updated Jun 15, 2023

In Brief

A clinical study evaluating High carotenoid juice and Placebo control - Apple juice for Dietary Habits and Diet, Healthy. Completed, enrolled 162 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedAug 14, 2019
Enrollment StartJun 28, 2021
Primary CompletionApr 14, 2022
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 6.9 years ago

Interventions

High carotenoid juicedietary

Juice with high carotenoids

Placebo control - Apple juicedietary

Juice with negligible carotenoids