Clinical trial NCT01288313: Effect of n-3 Polyunsaturated Fatty Acids Supplementation on Human Milk Composition of Lactating Women
Official title: Effect of N-3 Polyunsaturated Fatty Acids Supplementation on the Human Milk Composition of Lactating Women: Nutritional Intervention With Rapeseed Oil and n-3 Margarine Compared to Standard Olive Oil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Women
Keywords: human milk
polyunsaturated fatty acids
linolenic acid
rapeseed oil
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: ITERG
First posted: 2011-02-02
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acide linolenic 18 :3 n-3 analysis measured at day 30, compared to day 15
timeFrame: 30 days
Secondary outcomes:
measure: Analysis of linolenic acid and linoleic acid ratio
timeFrame: 30 days
measure: Analysis of arachidonic acid, docosahexanoic acid and their ratio
timeFrame: 30 days
measure: Comparison of fatty acid composition of human milk before and after supplementation
timeFrame: 30 days
measure: Analysis of trans fatty acids according diets
timeFrame: 30 days
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Lactarium Hôpital Pellegrin Enfants CHU Bordeaux
city: Lyon
country: France
facility: Lactarium CHU La Croix Rousse Lyon Néonatologie et Réanimation Néonatale
city: Montpellier
country: France
facility: Lactarium CHU Montpellier Pédiatrie 2
city: Paris
country: France
facility: Lactarium Institut de Puériculture de Paris et de Périnatalogie
Study officials:
affiliation: University Hospital Bordeaux (France)
name: Paul PEREZ, MD, PhD
role: STUDY_CHAIR
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