Baylor Infant Biomarker of Nutrition Study

Terminated

Conditions: Healthy Infant Nutrition

Registration Number: NCT03996395

Lead Sponsor: Baylor College of Medicine

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 21

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of Skin Carotenoid Score Measurements- 4 Month Olds.	1 day each	Time required to measure skin carotenoid score in 4 month olds. Units: seconds Scale: \>0 seconds Interpretation: Lower numbers indicate faster, more favorable durations for measurements. Range: 35-158 s
Infant Plasma Carotenoid Concentration, 4 Months.	1 day	Infant Plasma Total Carotenoid Concentration, 4 months.
Total Carotenoid Intake, 4 Month Olds	7 days	Total Carotenoid Intake per day, 4 month olds, assessed by 7 day food diary
Skin Carotenoid Scores in 4 Month Olds.	Measurements collected at the visit held when participants were 4 months of age.	Skin carotenoid scores in 4 month olds. Scale: 0-800 skin carotenoid score units. Interpretation: Greater numbers indicate a greater, theoretically more favorable, skin carotenoid concentration than lower scores. Range: 14-215

Secondary Outcome Measures

Name	Time	Method
Daily Total Carotenoid Intake, 6 and 8 Month Olds	7 days prior to the visits held at 6 months of age and at 8 months of age.	Total Carotenoid Intake per Day (average) Units: micrograms Scale: \>0 micrograms Range: 100 - 7660
Time Required for Carotenoid Score Measurement, 6 and 8 Month Olds.	Measurements conducted at the study visit held at either 6 months of age of 8 months of age.	Time Required for skin carotenoid score measurement, 6 and 8 month olds. Units: Seconds Scale: \>0 Interpretation: Smaller durations indicate a more feasible, favorable duration Range: 37s - 133s
Time Required for Skin Carotenoid Score Measurement, 6 and 8 Month Olds.	Measurements conducted at the study visit held at either 6 months of age of 8 months of age.	Time Required for Heel Skin Carotenoid Score Measurement, 6 and 8 Month Olds.
Skin Carotenoid Scores in 6 and 8 Month Olds.	Single day at either 6 months of age of 8 months of age.	Skin carotenoid scores in 6 and 8 month olds. Units: skin carotenoid score units on a scale Scale: 0-800 Interpretation: Greater numbers indicate a greater, theoretically more favorable, skin carotenoid concentration than lower scores. Range: 40-324
Skin Carotenoid Scores in 6 and 8 Month Olds	Single day at either 6 months of age of 8 months of age.	Skin carotenoid scores in 4 month olds. Unit: Skin Carotenoid Score Scale: 0-800 skin carotenoid score units Interpretation: Greater numbers indicate a greater, theoretically more favorable, skin carotenoid concentration than lower scores. Range: 59-200