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

Utah State University

Status: Completed

Conditions: Children, Only; Raman Spectroscopy

Treatments: Other: Feeding trial

Study type: Interventional

Funder types: Other

Identifiers

NCT03146715

USU #6351

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

High-carotenoid food feeding trial

Active Comparator group

Description:

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

Treatment:

Other: Feeding trial

No-carotenoid food feeding trial

Placebo Comparator group

Description:

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

Treatment:

Other: Feeding trial