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Completed

NCT Number: NCT01288313

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

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

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lactarium Hôpital Pellegrin Enfants CHU Bordeaux, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutritional intervention

Dietary Supplement

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 receive 30gr/day rapeseed oil. 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.

Primary outcomes

  1. Acide linolenic 18 :3 n-3 analysis measured at day 30, compared to day 15

    Time frame: 30 days

Secondary outcomes

  1. Analysis of linolenic acid and linoleic acid ratio

    Time frame: 30 days

  2. Analysis of arachidonic acid, docosahexanoic acid and their ratio

    Time frame: 30 days

  3. Comparison of fatty acid composition of human milk before and after supplementation

    Time frame: 30 days

  4. Analysis of trans fatty acids according diets

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • ITERG

Registry information

Official study 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

Acronym: Oméga 3

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 2, 2011
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.