Baylor Infant and Toddler Biomarker of Nutrition Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-24
SponsorBaylor College of Medicine

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Carotenoid Intake

    Other intervention

    Carotenoid intake calculated from food diary records reported by guardians.

  • Serum carotenoid concentrations

    Other intervention

    Serum carotenoid concentrations measured by HPLC.

Treatment groups

208 Participants
are divided into 1 treatment group
Group A: Observational Group2 interventions

Trial outcomes

Primary outcomes

1

Skin Carotenoid Score-4 months

Finger skin carotenoid score measured by pressure-mediated reflection spectroscopy

Time frame
4 months of age
2

Skin Carotenoid Score-6 months

Finger skin carotenoid score measured by pressure-mediated reflection spectroscopy

Time frame
6 months of age
3

Skin Carotenoid Score-8 months

Finger skin carotenoid score measured by pressure-mediated reflection spectroscopy

Time frame
8 months of age
4

Skin Carotenoid Score-12 months

Finger skin carotenoid score measured by pressure-mediated reflection spectroscopy

Time frame
12 months of age

Secondary outcomes

1

Contrast Sensitivity - 4 months

Contrast sensitivity measured by Mayer-Kran Double Happy Test

Time frame
4 months of age
2

Contrast Sensitivity - 6 months

Contrast sensitivity measured by Mayer-Kran Double Happy Test

Time frame
6 months of age
3

Contrast Sensitivity - 8 months

Contrast sensitivity measured by Mayer-Kran Double Happy Test

Time frame
8 months of age
4

Contrast Sensitivity - 12 months

Contrast sensitivity measured by Mayer-Kran Double Happy Test

Time frame
12 months of age

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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