Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05869760
Status:
RECRUITING
Last Update Posted:
2023-09-14
First Post:
2023-05-12
Brief Title:
Baylor Infant and Toddler Biomarker of Nutrition Study
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Observational Validation of Skin Carotenoid Biomarker of Infant and Toddler Carotenoid Intake
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BITBONS
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 childs 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 childs 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
The purpose of this study is to determine how a childs 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 childs 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 FVs 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 FV 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 childrens 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 childrens 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
Carotenoids are fat-soluble pigments found primarily in fruits and vegetables FVs 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 FV 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 childrens 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 childrens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HD111555 | NIH | None | httpsreporternihgovquickSearch1R01HD111555 |