Baylor Infant and Toddler Biomarker of Nutrition Study (BITBONS)

Observational Validation of Skin Carotenoid Biomarker of Infant and Toddler Carotenoid Intake

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Diet; Healthy Nutrition
• Intervention / Treatment: Other: Carotenoid Intake; Other: Serum carotenoid concentrations

Detailed Description

Early life nutrition is recognized as key determinant of short- and long-term health. However, a lack of objective, reliable, and valid methods to determine what exactly children makes it difficult to carefully study nutrition in infants and toddlers.

Carotenoids are fat-soluble pigments found primarily in fruits and vegetables (F&Vs) that support healthy functioning. Carotenoids support vitamin A requirements, reduce inflammation and cancer risk, and support cognitive, visual, and cardiovascular health. Since carotenoids are colorful, researchers can easily measure them in blood and tissues using color-measuring devices. Blood carotenoid concentrations are used as biomarkers of adult F&V intake. Advances in carotenoid measurement technologies may make carotenoid biomarker measures in children more feasible. However, the precision and accuracy of these biomarkers in children is not as well understood.

With better measures of carotenoid intake comes the opportunity to understand how carotenoid intake relates to children's health. A high priority area to investigate in this young children is whether dietary carotenoids are associated with visual function. Lutein and zeaxanthin, carotenoids that accumulate in the back of the eye (macula), are associated with visual contrast sensitivity in children and adults, a visual function which may support children's interactions with their environments, but this association has not been sufficiently studied in healthy infants and toddlers. In this study, the investigators will define in infants and toddlers 1) the rigorous validation of a skin carotenoid biomarker of dietary intake and 2) the associations between carotenoid intake and visual function.

• Study Type: Observational
• Enrollment (Estimated): 208

Contacts and Locations

• Study Contact: Name: Nancy E. Moran, PhD; Phone Number: 713-798-0520; Email: Nancy.Moran@bcm.edu
• Study Contact Backup: Name: Teresia M. O'Connor, MD, MPH; Phone Number: 713-798-6782; Email: teresiao@bcm.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine
      • Contact: Nancy E. Moran, PhD; Phone Number: 7137980520; Email: nancy.moran@bcm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

• 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
• guardian categorizes child as non-Hispanic white, Hispanic white, Asian, or non-Hispanic Black

Exclusion Criteria:

• physician-diagnosed metabolic, absorptive, or endocrine condition
• diagnosed food intolerance or allergy
• has a sibling enrolled in the study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational Group; Children will be followed from 4-24 months of age.	Other: Carotenoid Intake; Carotenoid intake calculated from food diary records reported by guardians.; Other: Serum carotenoid concentrations; Serum carotenoid concentrations measured by HPLC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Carotenoid Score-4 months	Finger skin carotenoid score measured by pressure-mediated reflection spectroscopy	4 months of age
Skin Carotenoid Score-6 months	Finger skin carotenoid score measured by pressure-mediated reflection spectroscopy	6 months of age
Skin Carotenoid Score-8 months	Finger skin carotenoid score measured by pressure-mediated reflection spectroscopy	8 months of age
Skin Carotenoid Score-12 months	Finger skin carotenoid score measured by pressure-mediated reflection spectroscopy	12 months of age
Skin Carotenoid Score-18 months	Finger skin carotenoid score measured by pressure-mediated reflection spectroscopy	18 months of age
Skin Carotenoid Score-24 months	Finger skin carotenoid score measured by pressure-mediated reflection spectroscopy	24 months of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast Sensitivity - 4 months	Contrast sensitivity measured by Mayer-Kran Double Happy Test	4 months of age
Contrast Sensitivity - 6 months	Contrast sensitivity measured by Mayer-Kran Double Happy Test	6 months of age
Contrast Sensitivity - 8 months	Contrast sensitivity measured by Mayer-Kran Double Happy Test	8 months of age
Contrast Sensitivity - 12 months	Contrast sensitivity measured by Mayer-Kran Double Happy Test	12 months of age
Contrast Sensitivity - 18 months	Contrast sensitivity measured by Mayer-Kran Double Happy Test	18 months of age
Contrast Sensitivity - 24 months	Contrast sensitivity measured by Mayer-Kran Double Happy Test	24 months of age

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of Houston; East Carolina University

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2023
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: May 12, 2023
• First Submitted That Met QC Criteria: May 12, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: biomarkers; toddler; infant; food intake; contrast sensitivity; carotenoids; visual development; skin carotenoids
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antioxidants; Protective Agents; Carotenoids
• Other Study ID Numbers: H-52929; 1R01HD111555 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No