Baylor Infant Biomarker of Nutrition Study (BIBS)

Non-invasive Marker of Infant Food Intake

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

Study Overview

• Status: Terminated
• Conditions: Healthy Infant Nutrition

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.

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 9 months (Child)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Infants; Infants, 4-4.5 months of age at enrollment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Skin Carotenoid Score Measurements- 4 Month Olds.	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	1 day each
Infant Plasma Carotenoid Concentration, 4 Months.	Infant Plasma Total Carotenoid Concentration, 4 months.	1 day
Total Carotenoid Intake, 4 Month Olds	Total Carotenoid Intake per day, 4 month olds, assessed by 7 day food diary	7 days
Skin Carotenoid Scores in 4 Month Olds.	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	Measurements collected at the visit held when participants were 4 months of age.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Required for Carotenoid Score Measurement, 6 and 8 Month Olds.	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	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.	Time Required for Heel 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.
Skin Carotenoid Scores in 6 and 8 Month Olds.	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	Single day at either 6 months of age of 8 months of age.
Skin Carotenoid Scores in 6 and 8 Month Olds	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	Single day at either 6 months of age of 8 months of age.
Daily Total Carotenoid Intake, 6 and 8 Month Olds	Total Carotenoid Intake per Day (average) Units: micrograms Scale: >0 micrograms Range: 100 - 7660	7 days prior to the visits held at 6 months of age and at 8 months of age.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin carotenoid measurement feasibility in 6 and 8 month olds.	The time to acquire measurements at 6 and 8 months of age.	1 day
Skin carotenoid measurement reliability in 6 and 8 month olds.	The intra-class correlation of repeated skin carotenoid measurements collected at 6 and 8 months of age.	1 day
Validity of skin carotenoid intensity as a correlate of total carotenoid intake at 6 and 8 months of age.	The correlation between skin carotenoid intensity and with reported total carotenoid intake at 6 and 8 months of age.	1 day
Validity of skin carotenoid intensity as a correlate of plasma total carotenoids at 6 months.	The correlation between skin carotenoid intensity and with total plasma carotenoid concentrations at 6 months of age.	1 day
Correlation between reported total carotenoid intake with plasma total carotenoid concentrations at 4 and 6 months of age.	Correlation between reported total carotenoid intake with plasma total carotenoid concentrations at 4 and 6 months of age.	1 day
Correlation of plasma carotenoid species concentrations with blood lipoprotein cholesterol fractions at 4 months.	Correlation of plasma carotenoid species concentrations with blood lipoprotein cholesterol fractions at 4 months.	1 day
Determinants of skin carotenoid and plasma carotenoid outcomes across 4, 6, 8 months of age.	Generalized linear mixed model to test the significant determinants and interactions impacting skin carotenoid and plasma carotenoid outcomes across infancy.	3 days

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Investigators: Principal Investigator: Nancy E. Moran, PhD, Baylor College of Medicine

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: June 21, 2019
• First Submitted That Met QC Criteria: June 21, 2019
• First Posted (Actual): June 24, 2019

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: September 11, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: biomarker; nutrition; infant; fruit; complementary feeding; vegetable; reflectance spectroscopy
• Other Study ID Numbers: H-43692

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No