Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-25 @ 9:40 PM
Study NCT ID:
NCT03996395
Status:
TERMINATED
Last Update Posted:
2024-11-15
First Post:
2019-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Baylor Infant Biomarker of Nutrition Study
Sponsor:
Baylor College of Medicine
Organization:
Study Overview
Official Title:
Non-invasive Marker of Infant Food Intake
Status:
TERMINATED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The COVID-19 pandemic made the recruitment and follow-up of this study impractical.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIBS
Brief Summary:
The study evaluates the the utility of a non-invasive skin measurement as a biomarker of infant food intake during complementary feeding.
Detailed Description:
RATIONALE: During infancy, children go from consuming primarily breast milk or formula, to consuming a variety of baby foods and table foods. Doctors, researchers, and community health workers are interested in knowing what foods infants eat, but since many infants have multiple adult caregivers, it can be hard for one caregiver to accurately recall the dietary pattern of the infant. A rapid, non-invasive biomarker of food intake in infants could serve as a useful monitoring tool.
PURPOSE: In order to develop a non-invasive measure of infant food intake, the association between infant dietary patterns, skin carotenoids, and blood carotenoids will be evaluated at 4, 6, and 8 months of age.
OUTLINE: Infants will visit the research center at 4, 6, and 8 months of age for length, weight, skinfold thickness, and skin colorant measures. An infant blood sample will be collected at each visit and lactating mothers will be asked to provide a breast milk sample. The caregiver will complete a food survey at each visit, will keep an infant food diary for a week at 4, 6, and 8 months of age, and will enter the food diaries into an online survey 3 times during each of the diary weeks.
PURPOSE: In order to develop a non-invasive measure of infant food intake, the association between infant dietary patterns, skin carotenoids, and blood carotenoids will be evaluated at 4, 6, and 8 months of age.
OUTLINE: Infants will visit the research center at 4, 6, and 8 months of age for length, weight, skinfold thickness, and skin colorant measures. An infant blood sample will be collected at each visit and lactating mothers will be asked to provide a breast milk sample. The caregiver will complete a food survey at each visit, will keep an infant food diary for a week at 4, 6, and 8 months of age, and will enter the food diaries into an online survey 3 times during each of the diary weeks.
Study Oversight
Has Oversight DMC:
False
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?: