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NCT04056624 · ClinicalTrials.gov registry record · NA

Examining Validity and Sensitivity of Pressure-Mediated Reflection Spectroscopy

A NA study, sponsored by East Carolina University.

Completed
Registry status
NA
Development phase
162
Enrollment target

NCT04056624: Completed NA study, sponsored by East Carolina University.

NCT04056624 is a NA study that has completed, run by East Carolina University. The registered enrollment target is 162 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04056624, a NA study, has completed, sponsored by East Carolina University.

COMPLETED
Registry status
NA
Development phase
162 participants
Enrollment target

Study 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.

Primary Outcome

Skin carotenoid level is a number from 0 to 800 that approximates carotenoids in the skin. The Veggie Meter device uses pressure mediated reflection spectroscopy to assess skin carotenoid level in the fingertip. Skin carotenoid levels are positively correlated with fruit and vegetable intake. A higher score generally indicates more fruit and vegetable intake, which is thought to be a better outcome. The primary outcome was change in skin carotenoid levels calculated by the skin carotenoid value

Interventions

  • DIETARY_SUPPLEMENT High carotenoid juice
  • DIETARY_SUPPLEMENT Placebo control - Apple juice

Trial Details

FieldValue
Enrollment Target 162 participants
Start Date 2021-06-28
Est. Completion 2022-04-14
Phase NA
East Carolina University

58 total trials

What the finished NCT04056624 record still lists

NCT04056624 is an interventional study that assigns participants to a tested intervention. The registered 162 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).

The record links to 0 conditions, and to 2 interventions - of which High carotenoid juice is the first listed.

NCT04056624 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04056624 about?

NCT04056624 is a clinical study titled "Examining Validity and Sensitivity of Pressure-Mediated Reflection Spectroscopy". 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 carote...

What is the current status of trial NCT04056624?

This trial is currently completed. It is a NA study. The enrollment target is 162 participants. The study started on 2021-06-28. Estimated completion is 2022-04-14.

What interventions are being tested in trial NCT04056624?

The interventions under investigation include: High carotenoid juice (DIETARY_SUPPLEMENT), Placebo control - Apple juice (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT04056624?

This trial is sponsored by East Carolina University, which has 58 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04056624's enrollment target sits among peer trials

162 627th of 2000 higher than 1,373 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04056624, the US trial registry maintained by the National Library of Medicine. NCT04056624 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.