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

NCT03146715 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-05-10

No results posted yet for this 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.

Conditions

  • Raman Spectroscopy
  • Children, Only

Interventions

OTHER

Feeding trial

Children were asked to eat the designated portion of the assigned food once a day for six weeks.

Sponsors & Collaborators

  • Utah Agriculture Experiment Station

    collaborator UNKNOWN

  • Utah State University

    lead OTHER

Principal Investigators

  • Karin Allen, PhD · Utah State University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-04-01
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

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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 NCT03146715 on ClinicalTrials.gov