Actively Recruiting

Age: 3Months - 24Months
All Genders
Healthy Volunteers
ID05869760

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

Age: 3Months - 24Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

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

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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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