Baylor Infant Biomarker of Nutrition Study

Healthy Infant Nutrition Clinical Trial

— BIBS  

Official title:

Non-invasive Marker of Infant Food Intake

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03996395
• Other study ID #: H-43692
• Status: Terminated
• Start date: April 8, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2022
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Months to 9 Months

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Infant Nutrition

Locations

Country	Name	City	State
United States	USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Skin carotenoid measurement feasibility in 6 and 8 month olds.	The time to acquire measurements at 6 and 8 months of age.	1 day
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	Skin carotenoid measurement feasibility in 4 month olds.	The time to acquire measurements at 4 months of age.	1 day each
Primary	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	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
Secondary	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