Baylor Infant Biomarker of Nutrition Study

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

Detailed Description
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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.

Official Title
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Non-invasive Marker of Infant Food Intake

Conditions
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Healthy Infant Nutrition

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 9 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infants<br>Infants, 4-4.5 months of age at enrollment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin carotenoid measurement feasibility in 4 month olds. | The time to acquire measurements at 4 months of age. | 1 day each | 
| Skin carotenoid measurement reliability in 4 month olds. | The intra-class correlation of repeated skin carotenoid measurements collected at 4 months of age. | 1 day each | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity of skin carotenoid intensity as a correlate of total carotenoid intake at 4 months. | The correlation between skin carotenoid intensity and with reported total carotenoid intake at 4 months of age. | 1 day | 
| Validity of skin carotenoid intensity as a correlate of plasma total carotenoids at 4 months. | The correlation between skin carotenoid intensity and with total plasma carotenoid concentrations at 4 months of age. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vegetable, infant, biomarker, fruit, complementary feeding, nutrition, reflectance spectroscopy