Baylor Infant Biomarker of Nutrition Study (BIBS)

Baylor College of Medicine

Status: Terminated

Conditions: Healthy Infant Nutrition

Study type: Observational

Funder types: Other

Identifiers

NCT03996395

H-43692

Details and patient eligibility

About

The study evaluates the the utility of a non-invasive skin measurement as a biomarker of infant food intake during complementary feeding.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 4 to 9 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 4-4.5 months old at baseline
• born at term (>/=37 weeks gestation)
• within the 5th-95th weight-for-age percentile (inclusive)
• primary caregiver can speak, read, and understand English
• infants are exclusively breast- and/or formula-feeding at baseline
• consenting parent or caregiver must be 18 years old or older

Exclusion criteria

• has a sibling enrolled in the study
• metabolic, digestive, or malabsorptive disorders
• known bleeding or clotting disorder
• requires a special diet
• exposed to tobacco smoke in the home
• currently taking any isolated carotenoid supplements
• using medications or complementary or alternative medications that interfere with dietary fat absorption
• has a history of endocrine disorders requiring hormone administration.

Trial design

21 participants in 1 patient group

Infants

Description:

Infants, 4-4.5 months of age at enrollment