Recruiting

Nutrition Biomarkers

Sponsor:

Baylor College of Medicine

Code:

NCT05869760

Conditions

Healthy Nutrition

Healthy Diet

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Accepted

Interventions

Carotenoid Intake

Serum carotenoid concentrations

Study Details

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

Study ID

NCT05869760

Start date

Jun 26, 2023

Status verified date

Mar, 2026

Completion date

Nov 30, 2028

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Accepted

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 Design

Enrollment

208 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational Group

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

Interventions

Carotenoid Intake

Carotenoid intake calculated from food diary records reported by guardians.

Serum carotenoid concentrations

Serum carotenoid concentrations measured by HPLC.

Primary outcome measure

  • Skin Carotenoid Score-4 months [ Time Frame: 4 months of age ]
  • Skin Carotenoid Score-6 months [ Time Frame: 6 months of age ]
  • Skin Carotenoid Score-8 months [ Time Frame: 8 months of age ]
  • Skin Carotenoid Score-12 months [ Time Frame: 12 months of age ]
  • Skin Carotenoid Score-18 months [ Time Frame: 18 months of age ]
  • Skin Carotenoid Score-24 months [ Time Frame: 24 months of age ]

Central Contacts and Locations

Central contacts

Teresia M. O'Connor, MD, MPH

713-798-6782teresiao@bcm.edu

Locations

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

Recruiting

Houston, Texas, United States, 77030

Contacts

More Information

Sponsor

Baylor College of Medicine

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2026-03-27.