Clinical trial NCT03996395: Baylor Infant Biomarker of Nutrition Study
Official title: Non-invasive Marker of Infant Food Intake
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Healthy Infant Nutrition
Keywords: infant
biomarker
fruit
vegetable
complementary feeding
nutrition
reflectance spectroscopy
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 21
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited using the CNRC and BCM clinical study recruitment websites and listservs, the CNRC volunteer database, word of mouth, and approved flyers posted on the BCM campus, the Texas Children's Health Plan Center for Women and Children clinics, the Texas Children's Hospital/Baylor College of Medicine (TCH/BCM) pediatric clinics, and the TCH/BCM obstetrics and gynecology clinics. We will also distribute flyers in-person (pending the permission of the clinic) in the waiting rooms of the TCH/BCM pediatrics and Texas Children's Health Plan Clinic and at sites throughout the community.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Duration of Skin Carotenoid Score Measurements- 4 Month Olds.
timeFrame: 1 day each
measure: Infant Plasma Carotenoid Concentration, 4 Months.
timeFrame: 1 day
measure: Total Carotenoid Intake, 4 Month Olds
timeFrame: 7 days
measure: Skin Carotenoid Scores in 4 Month Olds.
timeFrame: Measurements collected at the visit held when participants were 4 months of age.
Secondary outcomes:
measure: Time Required for Carotenoid Score Measurement, 6 and 8 Month Olds.
timeFrame: Measurements conducted at the study visit held at either 6 months of age of 8 months of age.
measure: Time Required for Skin Carotenoid Score Measurement, 6 and 8 Month Olds.
timeFrame: Measurements conducted at the study visit held at either 6 months of age of 8 months of age.
measure: Skin Carotenoid Scores in 6 and 8 Month Olds.
timeFrame: Single day at either 6 months of age of 8 months of age.
measure: Skin Carotenoid Scores in 6 and 8 Month Olds
timeFrame: Single day at either 6 months of age of 8 months of age.
measure: Daily Total Carotenoid Intake, 6 and 8 Month Olds
timeFrame: 7 days prior to the visits held at 6 months of age and at 8 months of age.
Other outcomes:
Locations:
city: Houston
country: United States
facility: USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Nancy E. Moran, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Juneja S, Chang J, Nguyen T, Castaneda R, O'Connor TM, Musaad S, Moran NE. The relative validity of nutrition assessment methods for estimating infant carotenoid intake differs by assessment tool, nutrient database, and milk carotenoid adjustment method. Nutr Res. 2024 Aug;128:38-49. doi: 10.1016/j.nutres.2024.06.003. Epub 2024 Jun 13.
citation: Moran NE, Chang J, Stroh R, Zaidi Y, Hason N, Musaad S, O'Connor T. Noninvasive Reflection Spectroscopy Measurement of Skin Carotenoid Score in Infants Is Feasible and Reliable. J Nutr. 2023 Jan 14;152(12):2966-2977. doi: 10.1093/jn/nxac182.