About this trial
Young children rely on their foods and drinks for the nutrients they need to grow, like energy, protein, vitamins, and minerals. In addition to nutrients, there are substances in fruits, vegetables, milk and formula, called phytochemicals, that can support health. While researchers know more about the role of phytochemicals in adult health, researchers know surprisingly little about how phytochemicals can support health in young children. One group of phytochemicals are called the carotenoids. Carotenoids are responsible for the red, orange, and yellow colors in some fruits and vegetables. In adults, carotenoids can support visual function. Researchers also know that measuring levels of carotenoids in the blood or optically in the skin, can serve as an indirect measurement of what child and adults eat.
The purpose of this study is to determine how a child's usual intake of carotenoids is related to their visual development and their blood and skin levels of carotenoids. The study involves 6 visits. For each visit, we will ask about the child's recent diet, will measure their body size, collect a blood sample, collect optical measurements of their skin, and will test how sharp their vision is.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
healthy
born at term (more than or equal to 37 weeks gestation)
between the 1st to 99th weight for age percentile at 3 months of age
participating guardian speaks, reads, and understands English
Disqualifiers
physician-diagnosed metabolic, absorptive, or endocrine condition
diagnosed food intolerance or allergy
has a sibling enrolled in the study
Trial population
Healthy infants and toddlers, born at term, and who are between the 1st and 99th percentile will be enrolled at 3 months of age. Children are categorized by their adult guardian as non-Hispanic white, Hispanic white, Asian, or non-Hispanic Black. Child participants are free of physician diagnosed metabolic, absorptive, or endocrine conditions, do not have diagnosed food intolerances or allergies, and do not have a sibling enrolled in the study.
Trial design
Cohort
Prospective
Treatments tested in this trial
Carotenoid Intake
Other interventionCarotenoid intake calculated from food diary records reported by guardians.
Serum carotenoid concentrations
Other interventionSerum carotenoid concentrations measured by HPLC.
Treatment groups
Trial outcomes
Primary outcomes
Skin Carotenoid Score-4 months
Finger skin carotenoid score measured by pressure-mediated reflection spectroscopy
Skin Carotenoid Score-6 months
Finger skin carotenoid score measured by pressure-mediated reflection spectroscopy
Skin Carotenoid Score-8 months
Finger skin carotenoid score measured by pressure-mediated reflection spectroscopy
Skin Carotenoid Score-12 months
Finger skin carotenoid score measured by pressure-mediated reflection spectroscopy
Secondary outcomes
Contrast Sensitivity - 4 months
Contrast sensitivity measured by Mayer-Kran Double Happy Test
Contrast Sensitivity - 6 months
Contrast sensitivity measured by Mayer-Kran Double Happy Test
Contrast Sensitivity - 8 months
Contrast sensitivity measured by Mayer-Kran Double Happy Test
Contrast Sensitivity - 12 months
Contrast sensitivity measured by Mayer-Kran Double Happy Test
Sponsors and contacts
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Baylor College of Medicine
Lead sponsor
University of Houston
Collaborator
East Carolina University
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator