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

NCT03146715 | Completed

• 1 other identifier: USU #6351
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Raman Spectroscopy; Children, Only

Outcome Measures

Primary Outcomes (1)

• Raman resonance spectroscopy

  The 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.

  6 weeks

Study Arms (2)

High-carotenoid food feeding trial

ACTIVE COMPARATOR

Twenty-three children were randomly assigned to a treatment with a high carotenoid baked food (4.3mg carotenoids/120g, 360 kcal)

Other: Feeding trial

No-carotenoid food feeding trial

PLACEBO COMPARATOR

Twenty-five children were randomly assigned to consume a baked food with no carotenoids (300 kcals/73g)

Other: Feeding trial

Interventions

Feeding trial OTHER

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

High-carotenoid food feeding trial; No-carotenoid food feeding trial

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Utah State University: lead
• Utah Agriculture Experiment Station: collaborator

Study Sites (1)

Utah State University, Center for Human Nutrition Studies

Logan, Utah, 84322-9815, United States

Location

Study Officials

• Karin Allen, PhD

  Utah State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: May 10, 2017
• Study Start: April 1, 2015
• Primary Completion: June 30, 2015
• Study Completion: June 30, 2015
• Last Updated: May 10, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)