Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03146715
Enrollment
48
Registered
2017-05-10
Start date
2015-04-01
Completion date
2015-06-30
Last updated
2017-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Only, Raman Spectroscopy

Brief 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

OTHERFeeding trial

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

Sponsors

Utah Agriculture Experiment Station
CollaboratorUNKNOWN
Utah State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* Skin carotenoid levels 11,000-33,000 Raman intensity counts * Age 5-18 years * Willing to attend 7 clinic visits * Willing to eat designated food each day for 6 weeks

Exclusion criteria

* Illness in two weeks before study began * Chronic disease such as asthma, rheumatoid arthritis, type 1 diabetes * Skin carotenoid levels \<11,000 and \>33,000 Raman intensity counts * Consumption of high carotenoid supplements * Use of topical self-tanning lotion

Design outcomes

Primary

MeasureTime frameDescription
Raman resonance spectroscopy6 weeksThe skin carotenoid levels were determined by calculating the average height of the peak Raman absorbance signal obtained and quantified from excitation of skin carotenoids using a low-intensity blue light-emitting diodes light (λ=473 nm) with green light (510 nm) detection.24 The BioPhotonic Scanner Everest 2TM skin carotenoids were reported as Raman intensity counts. The higher the count, the higher the concentration of carotenoid molecules detected at the site of measurement. The scanner reports total carotenoid count, rather than individual carotenoid counts, as there is overlap in the absorption spectra of each carotenoid. During the warm-up process, the black calibration cap, which covers the scanner's light-emitting diodes light, allows the scanner to self-calibrate using a patented process.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026