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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University Hospital, Bordeaux
Sponsor:
Collaborator:
ITERG
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01288313
First received: January 31, 2011
Last updated: November 21, 2013
Last verified: November 2013

January 31, 2011
November 21, 2013
September 2011
December 2013   (final data collection date for primary outcome measure)
Acide linolenic 18 :3 n-3 analysis measured at day 30, compared to day 15 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01288313 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effect of n-3 Polyunsaturated Fatty Acids Supplementation on Human Milk Composition of Lactating Women
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

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Nursing Women
  • 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.
  • 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.
  • 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.
  • 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.
  • Experimental: rapeseed oil
    Intervention: Dietary Supplement: nutritional intervention
  • Experimental: n-3 margarine and rapeseed oil
    Intervention: Dietary Supplement: nutritional intervention
  • Experimental: n-3 margarine
    Intervention: Dietary Supplement: nutritional intervention
  • Active Comparator: Olive oil
    Intervention: Dietary Supplement: nutritional intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 55 Years
Yes
Contact: Claude BILLEAUD, MD +33 (0)5 56 79 56 35 claude.billeaud@chu-bordeaux.fr
France
 
NCT01288313
2010/35, 2008-058
No
University Hospital, Bordeaux
University Hospital, Bordeaux
ITERG
Study Chair: Paul PEREZ, MD, PhD University Hospital Bordeaux (France)
University Hospital, Bordeaux
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP