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

This study has been completed.
Sponsor:
Collaborator:
ITERG
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01288313
First received: January 31, 2011
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention
Nursing Women
Dietary Supplement: nutritional intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Acide linolenic 18 :3 n-3 analysis measured at day 30, compared to day 15 [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analysis of linolenic acid and linoleic acid ratio [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Analysis of arachidonic acid, docosahexanoic acid and their ratio [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Comparison of fatty acid composition of human milk before and after supplementation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Analysis of trans fatty acids according diets [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: September 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rapeseed oil Dietary Supplement: nutritional intervention
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.
Experimental: n-3 margarine and rapeseed oil Dietary Supplement: nutritional intervention
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 diet associating 30gr/day of 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.
Experimental: n-3 margarine Dietary Supplement: nutritional intervention
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 with 30gr/day 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.
Active Comparator: Olive oil Dietary Supplement: nutritional intervention
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 receive 30gr/day olive oil (standard group. 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.

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01288313

Locations
France
Lactarium Hôpital Pellegrin Enfants CHU Bordeaux
Bordeaux, France, 33076
Lactarium CHU La Croix Rousse Lyon Néonatologie et Réanimation Néonatale
Lyon, France, 69004
Lactarium CHU Montpellier Pédiatrie 2
Montpellier, France, 34925
Lactarium Institut de Puériculture de Paris et de Périnatalogie
Paris, France, 75014
Sponsors and Collaborators
University Hospital, Bordeaux
ITERG
Investigators
Study Chair: Paul PEREZ, MD, PhD University Hospital Bordeaux (France)
  More Information

Publications:

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01288313     History of Changes
Other Study ID Numbers: 2010/35, 2008-058
Study First Received: January 31, 2011
Last Updated: August 19, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
human milk
polyunsaturated fatty acids
linolenic acid
rapeseed oil

ClinicalTrials.gov processed this record on August 20, 2014