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

Children, Only Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03146715
• Other study ID #: USU #6351
• Status: Completed
• Phase: N/A
• First received: April 20, 2017
• Last updated: May 5, 2017
• Start date: April 1, 2015
• Est. completion date: June 30, 2015

Study information

• Verified date: May 2017
• Source: Utah State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 30, 2015
• Est. primary completion date: June 30, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Children, Only
• Raman Spectroscopy

Intervention

Other:
• Feeding trial
Children were asked to eat the designated portion of the assigned food once a day for six weeks.

Locations

Country	Name	City	State
United States	Utah State University, Center for Human Nutrition Studies	Logan	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Utah State University	Utah Agriculture Experiment Station

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (?=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