Clinical Trials Directory

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.