Plasma Profile of Exclusively Breastfed Infants

To characterize nutrient levels in breastfeeding infants and their mothers.

Study Overview

• Status: Completed
• Conditions: Breast Fed Infants

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 Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Fudan University of Shanghai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 3 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Breastfeeding infants and their mothers

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma carotenoids in breastfed infants	At visit 1 (enrollment)

Secondary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Xianfeng Zhao, MD, PhD, Abbott Nutrition, R&D China

Publications and helpful links

General Publications

• Xu X, Zhao X, Berde Y, Low YL, Kuchan MJ. Milk and Plasma Lutein and Zeaxanthin Concentrations in Chinese Breast-Feeding Mother-Infant Dyads With Healthy Maternal Fruit and Vegetable Intake. J Am Coll Nutr. 2019 Feb;38(2):179-184. doi: 10.1080/07315724.2018.1490934. Epub 2018 Sep 11.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: August 16, 2012
• First Submitted That Met QC Criteria: August 17, 2012
• First Posted (Estimate): August 21, 2012

Study Record Updates

• Last Update Posted (Estimate): January 21, 2015
• Last Update Submitted That Met QC Criteria: January 19, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: AK99