Baylor Infant and Toddler Biomarker of Nutrition Study

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT05869760
Status
Recruiting
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Conditions

  • Healthy Diet
  • Healthy Nutrition

Eligibility Criteria

Sex
ALL
Age
3 Months - 24 Months
Healthy Volunteers
Accepted

Interventions

  • Carotenoid Intake — OTHER
    Carotenoid intake calculated from food diary records reported by guardians.
  • Serum carotenoid concentrations — OTHER
    Serum carotenoid concentrations measured by HPLC.

Study Details

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.

Key Dates

Start date
Jun 26, 2023
Status verified
Mar 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2028

Study Design

Enrollment
208 participants (estimated)

Arms

  • Arm: Observational Group
    Children will be followed from 4-24 months of age.

Primary Outcome Measure

Skin Carotenoid Score-4 months [ Time Frame: 4 months of age ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
USDA/ARS Children's Nutrition Research Center, Baylor College of MedicineHoustonTexas77030
Nancy E. Moran, PhD
[email protected]
7137980520

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By research site
USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine· Houston, TX

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