Actively Recruiting
Observational Validation of Skin Carotenoid Biomarker of Infant and Toddler Carotenoid Intake
Led by Baylor College of Medicine · Updated on 2026-03-27
208
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
U
University of Houston
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how carotenoids, natural pigments found in colorful fruits and vegetables, relate to young children's nutrition and health, focusing especially on their visual development. This observational study aims to better understand the connection between carotenoid intake, levels in the skin and blood, and visual function in healthy infants and toddlers from 4 to 24 months old. The study is supported by Baylor College of Medicine and addresses the lack of precise ways to measure children's nutrient intake. The study follows infants and toddlers over six visits between 4 and 24 months of age. At each visit, researchers will collect information about the child's recent diet from guardians, measure body size, take blood samples to measure serum carotenoid concentrations, and use noninvasive optical devices to assess skin carotenoid levels. The research will also include tests of visual sharpness and contrast sensitivity to explore links between carotenoids and visual function. Participants will attend six visits during which diet, body measurements, blood, and skin carotenoid levels are regularly assessed alongside visual tests. Researchers will track skin carotenoid scores at each age milestone to validate the skin measurement as a biomarker of dietary intake. The study will monitor how carotenoid intake relates to visual contrast sensitivity, aiming to understand early nutrition’s role in visual development. Participation continues until 24 months of age, with all procedures designed to support young children's health and development.
CONDITIONS
Brief Title
Baylor Infant and Toddler Biomarker of Nutrition Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy infants and toddlers
- Born at term (37 weeks gestation or later)
- Between the 1st and 99th weight-for-age percentile at 3 months old
- Guardian speaks, reads, and understands English
- Guardian categorizes child as non-Hispanic white, Hispanic white, Asian, or non-Hispanic Black
You will not qualify if you...
- Diagnosed metabolic, absorptive, or endocrine condition
- Diagnosed food intolerance or allergy
- Has a sibling already enrolled in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 20 months
Participants are observed from 4 to 24 months of age to measure skin carotenoid levels and visual contrast sensitivity, alongside dietary carotenoid intake recorded by guardians.
Visits at 4, 6, 8, 12, 18, and 24 months of age
Trial Site Locations
Total: 1 location
1
USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
N
Nancy E. Moran, PhD
T
Teresia M. O'Connor, MD, MPH
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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