Effect of n-3 Polyunsaturated Fatty Acids Supplementation on Human Milk Composition of Lactating Women

Not Applicable

Completed

• Conditions: Nursing Women
• Interventions: Dietary Supplement: nutritional intervention

• Registration Number: NCT01288313
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

We propose to measure the LCPUFA human milk (linolenic acid, linoleic acid, docosahexaenoic acid, arachidonic acid) according to fatty acids nature and quantities consumed by lactating women

Detailed Description

n-3 and n-6 long chain polyunsaturated fatty acids (LCPUFA) are essential particularly to neurodevelopment of newborn infants. Many variations in essential PUFA and LCPUFA content of human milk are observed according to countries and dietary habits of the mothers.

Maternal diet supplementation of LCPUFA of lactating women may increase LCPUFA human milk according to consensus recommendations.

This clinical trial is performed to evaluate the effect of different of consumption of n-3 fatty acids (linolenic acid) in different forms (oils or margarine) in the human milk composition.

Each diet will last 30 days. During the first period of 15 days, the mothers will receive mediterranean diet based on olive oil. Then, lactating women will be randomised into four groups : one group will receive olive oil (standard group), one group supplemented in rapeseed oil, one group with n-3 margarine and one group with diet associating rapeseed oil and n-3 margarine.Human milk will be collected during the first breastfeeding of the day (10 ml) at three times : Days 0 corresponding to the usual diet , at day 15 after the Mediterranean diet and at day 30, after the study diet.

Study Timeline

• Study First Submitted: 2011-01-31
• Study First Submitted QC: 2011-01-31
• Study First Posted: 2011-02-02
• Study Start: 2011-09
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-19
• Last Update Posted: 2014-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

Inclusion Criteria

• Lactating women more than 1 month and less than 4 month with neonate whom term is between 37 and 42 gestational age
• Women who agree to consume fatty fish two times per week
• Free consent

Exclusion Criteria

• Women with multiple infants
• Chronic treatments more than 8 days
• Women with treatment during supplementation period
• Women with maternal pathology not compatible with breastfeed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
n-3 margarine and rapeseed oil	nutritional intervention	-
n-3 margarine	nutritional intervention	-
Olive oil	nutritional intervention	-
rapeseed oil	nutritional intervention	-

Primary Outcome Measures

Name	Time	Method
Acide linolenic 18 :3 n-3 analysis measured at day 30, compared to day 15	30 days

Secondary Outcome Measures

Name	Time	Method
Analysis of linolenic acid and linoleic acid ratio	30 days
Analysis of arachidonic acid, docosahexanoic acid and their ratio	30 days
Comparison of fatty acid composition of human milk before and after supplementation	30 days
Analysis of trans fatty acids according diets	30 days

Trial Locations

Locations (4)

Lactarium Institut de Puériculture de Paris et de Périnatalogie; 🇫🇷 Paris, France

Lactarium CHU Montpellier Pédiatrie 2; 🇫🇷 Montpellier, France

Lactarium Hôpital Pellegrin Enfants CHU Bordeaux; 🇫🇷 Bordeaux, France

Lactarium CHU La Croix Rousse Lyon Néonatologie et Réanimation Néonatale; 🇫🇷 Lyon, France