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

U

University Hospital of Bordeaux

Status

Completed

Conditions

Nursing Women

Treatments

Dietary Supplement: nutritional intervention

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01288313
2010/35
2008-058

Details and patient eligibility

About

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

Full 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.

Enrollment

82 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

82 participants in 4 patient groups

rapeseed oil
Experimental group
Treatment:
Dietary Supplement: nutritional intervention
Dietary Supplement: nutritional intervention
Dietary Supplement: nutritional intervention
Dietary Supplement: nutritional intervention
n-3 margarine and rapeseed oil
Experimental group
Treatment:
Dietary Supplement: nutritional intervention
Dietary Supplement: nutritional intervention
Dietary Supplement: nutritional intervention
Dietary Supplement: nutritional intervention
n-3 margarine
Experimental group
Treatment:
Dietary Supplement: nutritional intervention
Dietary Supplement: nutritional intervention
Dietary Supplement: nutritional intervention
Dietary Supplement: nutritional intervention
Olive oil
Active Comparator group
Treatment:
Dietary Supplement: nutritional intervention
Dietary Supplement: nutritional intervention
Dietary Supplement: nutritional intervention
Dietary Supplement: nutritional intervention

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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