Baylor Infant Biomarker of Nutrition Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-08

Study Completion Date

2020-12-31

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.

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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.

Conditions

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Healthy Infant Nutrition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Infants

Infants, 4-4.5 months of age at enrollment

No interventions assigned to this group

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.

Minimum Eligible Age

4 Months

Maximum Eligible Age

9 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes