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NCT03146715 · ClinicalTrials.gov registry record · NA

The Effect of a Nutrient Dense Food on the Skin CarotenoidLevels of School Age Children

A NA study, sponsored by Utah State University.

Completed
Registry status
NA
Development phase
48
Enrollment target

NCT03146715 is a NA study that has completed, run by Utah State University. The registered enrollment target is 48 participants.

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The verdict

NCT03146715, a NA study, has completed, sponsored by Utah State University.

COMPLETED
Registry status
NA
Development phase
48 participants
Enrollment target

Study Summary

Background: In a previous study, children who consumed a high-carotenoid juice over 8 weeks significantly increased skin carotenoid levels as compared to children who consumed a placebo juice. A naturally carotenoid-rich baked product, potentially marketable as a healthy breakfast food alternative, was developed by Utah State University researchers. Objective: To determine the effect and response of a carotenoid-rich baked product on change in skin carotenoid levels among children. Design: A six week randomized controlled trial. Participants/setting: Participants were children age 5-18 during March-June, 2015 living in Cache County, UT (n=46). Intervention: Children were randomly assigned to one of two groups: treatment (n=23) with a high carotenoid baked food or control (n=25) who consumed a baked food with no carotenoids. Children were asked to eat the designated portion of the assigned food once a day for six weeks. Skin carotenoid levels were measured every two weeks by a BioPhotonic scanner and reported in Raman intensity counts. Participants were asked to maintain their diet and completed a food frequency questionnaire at Baseline, Week 3, and Week 6. Uneaten portions of the food were returned to clinic, counted, and recorded. Main outcome measures: Change in skin carotenoid levels as measured in Raman counts over 6 weeks. Statistical analysis performed: Repeated-measures ANOVA was used to assess the group differences in Raman counts.

Interventions

  • OTHER Feeding trial

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2015-04-01
Est. Completion 2015-06-30
Phase NA

Sponsor

Utah State University

27 total trials

What the Registry Record Tells You About NCT03146715

The ClinicalTrials.gov registry entry for NCT03146715 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Utah State University, which has 27 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Feeding trial is the first listed.

NCT03146715 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03146715 about?

NCT03146715 is a clinical study titled "The Effect of a Nutrient Dense Food on the Skin CarotenoidLevels of School Age Children". Background: In a previous study, children who consumed a high-carotenoid juice over 8 weeks significantly increased skin carotenoid levels as compared to children who consumed a placebo juice. A naturally carotenoid-rich baked product, potentially marketable as a healthy breakfast food alternative, ...

What is the current status of trial NCT03146715?

This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2015-04-01. Estimated completion is 2015-06-30.

What interventions are being tested in trial NCT03146715?

The interventions under investigation include: Feeding trial (OTHER).

Who is sponsoring clinical trial NCT03146715?

This trial is sponsored by Utah State University, which has 27 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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