Trials / Completed
CompletedNCT03146715
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Utah State University · Academic / Other
- Sex
- All
- Age
- 5 Years – 18 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Feeding trial | Children were asked to eat the designated portion of the assigned food once a day for six weeks. |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2015-06-30
- Completion
- 2015-06-30
- First posted
- 2017-05-10
- Last updated
- 2017-05-10
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03146715. Inclusion in this directory is not an endorsement.