Plasma Profile of Exclusively Breastfed Infants

Abbott Nutrition1 site in 1 country56 target enrollmentJune 2012

ConditionsBreast Fed Infants

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Fed Infants
Sponsor: Abbott Nutrition
Enrollment: 56
Locations: 1
Primary Endpoint: Plasma carotenoids in breastfed infants
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To characterize nutrient levels in breastfeeding infants and their mothers.

Detailed Description

The objectives of this study are (1) to characterize plasma lutein levels in breastfed infants in an Asian population where lactating mothers have diets habitually high in lutein and (2) investigate how blood lutein levels in breastfed infants vary according to lutein content of the mothers' milk in such a population.

Registry

clinicaltrials.gov

Start Date

June 2012

End Date

December 2012

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Infant is judged to be in good health.
•Infant is a singleton from a full term birth.
•Infant's birth weight was \> 2490 g.
•Infant is between 6 weeks and 16 weeks (42 to 112 days).
•Infant must have been exclusively breastfed at enrollment.
•Mother's intake indicates a consumption of an average of at least three servings of fruit and/or vegetables per day.
•Mother is a non-smoker.
•Mother is in good health.
•Mother confirms her intention to continue breastfeeding.

Exclusion Criteria

•An adverse maternal, fetal or infant medical history that is thought to have potential for effects on growth, and/or development.
•Infants who have consumed medications or herbal preparations during past 14 days prior to enrollment.
•Infants who have consumed any solid or liquid foods or juices prior to enrollment.
•Infants who have received any supplements containing carotenoids prior to enrollment.
•Mother who is consuming dietary supplements containing carotenoids.
•Participation in another study that has not been approved as a concomitant study.

Outcomes

Primary Outcomes

Plasma carotenoids in breastfed infants

Time Frame: At visit 1 (enrollment)

Secondary Outcomes

Plasma carotenoids in mothers of breastfed infants(At visit 1 (enrollment))
Dietary carotenoid intake of mothers of breastfed infants(At visit 1 (enrollment) and visit 2 (14 days))
Carotenoid levels in breastmilk(At visit 1 (enrollment) and visit 2 (14 days))