Baylor Infant and Toddler Biomarker of Nutrition Study

NCT05869760 | Recruiting

• 2 other identifiers: H-529291R01HD111555
• Study Type: observational
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Nutrition; Healthy Diet

Keywords

infant; toddler; carotenoids; biomarkers; food intake; visual development; contrast sensitivity; skin carotenoids

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Contrast Sensitivity - 4 months

  4 months of age

• Contrast Sensitivity - 6 months

  6 months of age

• Contrast Sensitivity - 8 months

  8 months of age

• Contrast Sensitivity - 12 months

  12 months of age

• Contrast Sensitivity - 18 months

  18 months of age

Study Arms (1)

Observational Group

Children will be followed from 4-24 months of age.

Other: Carotenoid Intake; Other: Serum carotenoid concentrations

Interventions

Carotenoid Intake OTHER

Carotenoid intake calculated from food diary records reported by guardians.

Observational Group

Serum carotenoid concentrations OTHER

Serum carotenoid concentrations measured by HPLC.

Observational Group

Eligibility Criteria

• Age: 3 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma, human milk

Central Study Contacts

Nancy E. Moran, PhD

CONTACT

713-798-0520; nancy.moran@bcm.edu

Teresia M. O'Connor, MD, MPH

CONTACT

713-798-6782; teresiao@bcm.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: May 22, 2023
• Study Start: June 26, 2023
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)