Trials / Terminated
TerminatedNCT03996395
Baylor Infant Biomarker of Nutrition Study
Non-invasive Marker of Infant Food Intake
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 21 (actual)
- Sponsor
- Baylor College of Medicine · Academic / Other
- Sex
- All
- Age
- 4 Months – 9 Months
- Healthy volunteers
- Accepted
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.
Conditions
Timeline
- Start date
- 2019-04-08
- Primary completion
- 2020-12-31
- Completion
- 2020-12-31
- First posted
- 2019-06-24
- Last updated
- 2024-11-15
- Results posted
- 2024-11-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03996395. Inclusion in this directory is not an endorsement.