Study on Normal Ranges of Lipids in Breast Milk of Healthy Mothers

Completed

• Conditions: Healthy Mothers
• Interventions: Other: minimum 4 months of breastfeeding

• Registration Number: NCT01805011
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

This trial is undertaken to better understand the ranges of functional components normally found in human milk. This will strengthen the scientific knowledge on breast-milk composition as a "gold standard".

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Status Verified: 2011-09
• Primary Completion: 2012-05
• Study First Submitted: 2013-03-04
• Study First Submitted QC: 2013-03-04
• Last Update Submitted: 2013-03-04
• Study First Posted: 2013-03-05
• Last Update Posted: 2013-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Gestational age between 37 and not above 42 weeks
• 18 years old ≤ Mother ≤ 40 years old
• 18.5 ≤ pre-pregnancy BMI ≤ 29
• Mothers willing to breastfeed for the first 4 months

Exclusion Criteria

• Gestational diabetes
• HTA < 140/90
• Mothers who are smokers while breast-feeding

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
50 healthy mothers	minimum 4 months of breastfeeding	-

Primary Outcome Measures

Name	Time	Method
levels of lipids	After 1 month of Breastfeeding	The primary objective of this trial is to determine the levels of lipids normally found in the breast-milk of healthy lactating mothers

Secondary Outcome Measures

Name	Time	Method
profile and quantity of sugars	After 1 month of breastfeeding	Secondary objectives include the measure of the profile and quantity of sugars found in human milk