Plasma Profile of Exclusively Breastfed Infants

Completed

• Conditions: Breast Fed Infants

• Registration Number: NCT01669655
• Lead Sponsor: Abbott Nutrition

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-08-16
• Study First Submitted QC: 2012-08-17
• Study First Posted: 2012-08-21
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-19
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma carotenoids in breastfed infants	At visit 1 (enrollment)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Fudan University of Shanghai; 🇨🇳 Shanghai, Shanghai, China