- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03146715
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Utah
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Logan, Utah, United States, 84322-9815
- Utah State University, Center for Human Nutrition Studies
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: High-carotenoid food feeding trial
Twenty-three children were randomly assigned to a treatment with a high carotenoid baked food (4.3mg carotenoids/120g, 360 kcal)
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Children were asked to eat the designated portion of the assigned food once a day for six weeks.
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Placebo Comparator: No-carotenoid food feeding trial
Twenty-five children were randomly assigned to consume a baked food with no carotenoids (300 kcals/73g)
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Children were asked to eat the designated portion of the assigned food once a day for six weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Raman resonance spectroscopy
Time Frame: 6 weeks
|
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.
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6 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Karin Allen, PhD, Utah State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- USU #6351
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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