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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Nursing Women

Intervention / Treatment
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* Dietary Supplement: nutritional intervention
* Dietary Supplement: nutritional intervention
* Dietary Supplement: nutritional intervention
* Dietary Supplement: nutritional intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rapeseed oil<br> | Dietary Supplement: nutritional intervention<br>* 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.<br>|
| Experimental: n-3 margarine and rapeseed oil<br> | Dietary Supplement: nutritional intervention<br>* 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.<br>|
| Experimental: n-3 margarine<br> | Dietary Supplement: nutritional intervention<br>* 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.<br>|
| Active Comparator: Olive oil<br> | Dietary Supplement: nutritional intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acide linolenic 18 :3 n-3 analysis measured at day 30, compared to day 15 |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of linolenic acid and linoleic acid ratio |  | 30 days | 
| Analysis of arachidonic acid, docosahexanoic acid and their ratio |  | 30 days | 
| Comparison of fatty acid composition of human milk before and after supplementation |  | 30 days | 
| Analysis of trans fatty acids according diets |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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human milk, polyunsaturated fatty acids, linolenic acid, rapeseed oil