Healthy NutritionBITBONSNCT05869760
Baylor Infant and Toddler Biomarker of Nutrition Study
An observational study of Healthy Nutrition and Healthy Diet, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy Nutrition, Healthy Diet
- What is being tested?
- Carotenoid Intake and Serum carotenoid concentrations
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2023to 30 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- physician-diagnosed metabolic, absorptive, or endocrine condition
- diagnosed food intolerance or allergy
- has a sibling enrolled in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine
Houston, Texas, 77030
Nancy E. Moran, PhD, 7137980520, nancy.moran@bcm.edu
About this study
Official title: Observational Validation of Skin Carotenoid Biomarker of Infant and Toddler Carotenoid Intake
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.
Read the detailed description
Early life nutrition is recognized as key determinant of short- and long-term health. However, a lack of objective, reliable, and valid methods to determine what exactly children makes it difficult to carefully study nutrition in infants and toddlers.
Carotenoids are fat-soluble pigments found primarily in fruits and vegetables (F\&Vs) that support healthy functioning. Carotenoids support vitamin A requirements, reduce inflammation and cancer risk, and support cognitive, visual, and cardiovascular health. Since carotenoids are colorful, researchers can easily measure them in blood and tissues using color-measuring devices. Blood carotenoid concentrations are used as biomarkers of adult F\&V intake. Advances in carotenoid measurement technologies may make carotenoid biomarker measures in children more feasible. However, the precision and accuracy of these biomarkers in children is not as well understood.
With better measures of carotenoid intake comes the opportunity to understand how carotenoid intake relates to children's health. A high priority area to investigate in this young children is whether dietary carotenoids are associated with visual function. Lutein and zeaxanthin, carotenoids that accumulate in the back of the eye (macula), are associated with visual contrast sensitivity in children and adults, a visual function which may support children's interactions with their environments, but this association has not been sufficiently studied in healthy infants and toddlers. In this study, the investigators will define in infants and toddlers 1) the rigorous validation of a skin carotenoid biomarker of dietary intake and 2) the associations between carotenoid intake and visual function.
- Conditions
- Healthy Nutrition, Healthy Diet
- Being tested
- Carotenoid Intake, Serum carotenoid concentrations
- Keywords
- infant, toddler, carotenoids, biomarkers, food intake, visual development, contrast sensitivity, skin carotenoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotenoid IntakeOther
Carotenoid intake calculated from food diary records reported by guardians.
Serum carotenoid concentrationsOther
Serum carotenoid concentrations measured by HPLC.
| Study group | Role | What they receive |
|---|---|---|
| Observational Group | Children will be followed from 4-24 months of age. Receives: Other: Carotenoid Intake; Other: Serum carotenoid concentrations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Carotenoid Score-4 months
Finger skin carotenoid score measured by pressure-mediated reflection spectroscopy
Measured: 4 months of age
Skin Carotenoid Score-6 months
Finger skin carotenoid score measured by pressure-mediated reflection spectroscopy
Measured: 6 months of age
Skin Carotenoid Score-8 months
Finger skin carotenoid score measured by pressure-mediated reflection spectroscopy
Measured: 8 months of age
Skin Carotenoid Score-12 months
Finger skin carotenoid score measured by pressure-mediated reflection spectroscopy
Measured: 12 months of age
Skin Carotenoid Score-18 months
Finger skin carotenoid score measured by pressure-mediated reflection spectroscopy
Measured: 18 months of age
Skin Carotenoid Score-24 months
Finger skin carotenoid score measured by pressure-mediated reflection spectroscopy
Measured: 24 months of age
Secondary outcomes (6)
Contrast Sensitivity - 4 months
Contrast sensitivity measured by Mayer-Kran Double Happy Test
Measured: 4 months of age
Contrast Sensitivity - 6 months
Contrast sensitivity measured by Mayer-Kran Double Happy Test
Measured: 6 months of age
Contrast Sensitivity - 8 months
Contrast sensitivity measured by Mayer-Kran Double Happy Test
Measured: 8 months of age
Contrast Sensitivity - 12 months
Contrast sensitivity measured by Mayer-Kran Double Happy Test
Measured: 12 months of age
Contrast Sensitivity - 18 months
Contrast sensitivity measured by Mayer-Kran Double Happy Test
Measured: 18 months of age
Contrast Sensitivity - 24 months
Contrast sensitivity measured by Mayer-Kran Double Happy Test
Measured: 24 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start26 Jun 2023
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy NutritionStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Houston, East Carolina University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Nancy Engelmann Moran, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869760
- Sponsor's protocol ID
- H-52929
- Other IDs
- 1R01HD111555
- Acronym
- BITBONS
- Status last verified
- Mar 2026
- First submitted
- 12 May 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Validation of Skin Carotenoid Biomarker of Infant and Toddler Carotenoid Intake
- ClinicalTrials.gov ID
- NCT05869760
- Acronym / sponsor ID
- BITBONS / H-52929
- Conditions
- Healthy Nutrition, Healthy Diet
- Keywords
- infant, toddler, carotenoids, biomarkers, food intake, visual development, contrast sensitivity, skin carotenoids
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- University of Houston, East Carolina University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Early life nutrition is recognized as key determinant of short- and long-term health. However, a lack of objective, reliable, and valid methods to determine what exactly children makes it difficult to carefully study nutrition in infants and toddlers.
Carotenoids are fat-soluble pigments found primarily in fruits and vegetables (F\&Vs) that support healthy functioning. Carotenoids support vitamin A requirements, reduce inflammation and cancer risk, and support cognitive, visual, and cardiovascular health. Since carotenoids are colorful, researchers can easily measure them in blood and tissues using color-measuring devices. Blood carotenoid concentrations are used as biomarkers of adult F\&V intake. Advances in carotenoid measurement technologies may make carotenoid biomarker measures in children more feasible. However, the precision and accuracy of these biomarkers in children is not as well understood.
With better measures of carotenoid intake comes the opportunity to understand how carotenoid intake relates to children's health. A high priority area to investigate in this young children is whether dietary carotenoids are associated with visual function. Lutein and zeaxanthin, carotenoids that accumulate in the back of the eye (macula), are associated with visual contrast sensitivity in children and adults, a visual function which may support children's interactions with their environments, but this association has not been sufficiently studied in healthy infants and toddlers. In this study, the investigators will define in infants and toddlers 1) the rigorous validation of a skin carotenoid biomarker of dietary intake and 2) the associations between carotenoid intake and visual function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Group | – | Other: Carotenoid Intake, Other: Serum carotenoid concentrationsChildren will be followed from 4-24 months of age. |
Who may qualify
- Ages
- 3 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- physician-diagnosed metabolic, absorptive, or endocrine condition
- diagnosed food intolerance or allergy
- has a sibling enrolled in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotenoid IntakeCarotenoid intake calculated from food diary records reported by guardians. | Other | Observational Group |
| Serum carotenoid concentrationsSerum carotenoid concentrations measured by HPLC. | Other | Observational Group |
Primary outcome
Skin Carotenoid Score-4 months
Time frame: 4 months of age
Finger skin carotenoid score measured by pressure-mediated reflection spectroscopy
Skin Carotenoid Score-6 months
Time frame: 6 months of age
Finger skin carotenoid score measured by pressure-mediated reflection spectroscopy
Skin Carotenoid Score-8 months
Time frame: 8 months of age
Finger skin carotenoid score measured by pressure-mediated reflection spectroscopy
Skin Carotenoid Score-12 months
Time frame: 12 months of age
Finger skin carotenoid score measured by pressure-mediated reflection spectroscopy
Skin Carotenoid Score-18 months
Time frame: 18 months of age
Finger skin carotenoid score measured by pressure-mediated reflection spectroscopy
Skin Carotenoid Score-24 months
Time frame: 24 months of age
Finger skin carotenoid score measured by pressure-mediated reflection spectroscopy
6 secondary outcomes
Contrast Sensitivity - 4 months
Time frame: 4 months of age
Contrast Sensitivity - 6 months
Time frame: 6 months of age
Contrast Sensitivity - 8 months
Time frame: 8 months of age
Contrast Sensitivity - 12 months
Time frame: 12 months of age
Contrast Sensitivity - 18 months
Time frame: 18 months of age
Contrast Sensitivity - 24 months
Time frame: 24 months of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Nutrition and Healthy Diet, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy E. Moran, PhD (713-798-0520, nancy.moran@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Carotenoid Score-4 months (time frame: 4 months of age). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.