Does a Diet With the Recommended Amount of Polyunsaturated Fatty Acids, Increase Their Proportion in Maternal Milk?

Study Overview
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Brief Summary
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During pregnancy and lactation, the consumption of PUFA n-3, through the consumption of food products that contain more ALA than conventional products, could impact nutritional and non-nutritional breast milk quality (immune criteria, metabolites, hormones), and also the implantation of the intestinal microbiota of the newborn, which is involved in preservation of short term and long term health of the child.

Official Title
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Does a Diet With the Recommended Amount of Polyunsaturated Fatty Acids, Increase Their Proportion in Maternal Milk? A Prospective Randomized Open Study

Conditions
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Breast Feeding

Intervention / Treatment
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* Device: Dietary advice
* Other: Consumption of Bleu-Blanc-Coeur products
* Other: No consumption of Bleu-Blanc-Coeur products
* Biological: Blood sample
* Other: Contact
* Other: food questionnaire
* Other: newborn faeces sample
* Other: breast milk sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women over 18; ≤ 28th week of amenorrhea having a project of exclusive breastfeeding until at least the 45th day postpartum; BMI before pregnancy between 18.5 and 30.0; consuming frequently dairy products, eggs, meat (pork, beef, poultry); accepting the consumption of all food products delivered; written consent received and signed. Non-inclusion criteria: multiple pregnancy; eating disorders or suspicion (defined by SCOFF score); vegetarian, vegan or flexitarian; allergic to food product(s) involved in the study; home with more than 2 adults and 3 children (excluding foetus); adults on legal protection (guardianship, trusteeship…), persons deprived of liberty; Exclusion Criteria: Interruption of breastfeeding before the 21st postpartum day Prematurity: childbirth before the 37th week of amenorrhea

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day | Device: Dietary advice<br>* participants will benefit of dietary device 30-minute dietary advice carried out by a doctor at the University Hospital of Rennes, in order to provide nutritional advice adapted to pregnant women.<br>Other: Consumption of Bleu-Blanc-Coeur products<br>* consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day<br>Biological: Blood sample<br>* the fatty acid profile of the women red blood cells of the woman wil be test at the inclusion and at 21 days post-partum<br>Other: Contact<br>* Participants of the group A will be contacted by phone,sms, mail by a technician every 15 days from 7th month of pregnancy to the 8th month of pregnancy and then every week from the 9th month of pregnancy to the 45th postpartum day (except the week of childbirth), in order to collect their consumption data of the delivered food products.<br>Other: food questionnaire<br>* Participants will have to complete a food questionnaire at the inclusion and at 21 days post-partum<br>Other: newborn faeces sample<br>* Newborn faeces sample will be collected at 21 Days post partum<br>Other: breast milk sample<br>* Breast milk sample will be collected at 21 days and 45 days post partum<br>|
| Placebo Comparator: Control Group<br>no consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day. This group will receive Système U vouchers. | Device: Dietary advice<br>* participants will benefit of dietary device 30-minute dietary advice carried out by a doctor at the University Hospital of Rennes, in order to provide nutritional advice adapted to pregnant women.<br>Other: No consumption of Bleu-Blanc-Coeur products<br>* no consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day. This group will receive Système U vouchers.<br>Biological: Blood sample<br>* the fatty acid profile of the women red blood cells of the woman wil be test at the inclusion and at 21 days post-partum<br>Other: food questionnaire<br>* Participants will have to complete a food questionnaire at the inclusion and at 21 days post-partum<br>Other: newborn faeces sample<br>* Newborn faeces sample will be collected at 21 Days post partum<br>Other: breast milk sample<br>* Breast milk sample will be collected at 21 days and 45 days post partum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of α-linolenic acid in milk | The primary evaluation criterion is the level of α-linolenic acid in milk on the 21st postpartum day. | on the 21st postpartum day. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The α-linolenic acid level of breast milk | The α-linolenic acid level of breast milk at the 45th postpartum day; | at the 45th postpartum day; | 
| The fatty acid content of breast milk ; | The fatty acid content of breast milk on the 21st and the 45th postpartum days; | on the 21st and the 45th postpartum days | 
| The cytokine content of breast milk | The cytokine content of breast milk on the 21st and the 45th postpartum days: IL-6, TNFα, TGFβ | on the 21st and the 45th postpartum days | 
| The immunoglobulin A and G content of breast milk | The immunoglobulin A and G content of breast milk on the 21st and the 45th postpartum days; | on the 21st and the 45th postpartum days; | 
| The lactoferrin content (antimicrobial factor) of breast milk | The lactoferrin content (antimicrobial factor) of breast milk on the 21st and the 45th postpartum days; | on the 21st and the 45th postpartum days; | 
| The hormone content of breast milk | The hormone content of breast milk on the 21st and the 45th postpartum days: adiponectin, leptin, insulin; | on the 21st and the 45th postpartum days | 
| The oligosaccharide content of breast milk | The oligosaccharide content of breast milk on the 21st and the 45th postpartum days; | on the 21st and the 45th postpartum days | 
| The breast milk microbiota content | The breast milk microbiota content on the 21st and the 45th postpartum days; | on the 21st and the 45th postpartum days | 
| the bacterial intestinal microbiota content from the feces of the newborn | the bacterial intestinal microbiota content from the feces of the newborn on the 21st postpartum day; | on the 21st postpartum day; | 
| Fatty acid content | the fatty acid content of the women red blood cells of the woman before the 7th month of pregnancy and on the 21st postpartum day. | before the 7th month of pregnancy and on the 21st postpartum day. | 
| The breast milk lipidome | the breast milk lipidome on the 21st postpartum day: 26 lipid classes comprising more than 300 different lipid species (in addition to the total fatty acid analyses of breast milk, in order to make a complete description of the lipid species provided); | on the 21st postpartum day | 
| The maternal milk metabolome | the maternal milk metabolome on the 21st postpartum day: metabolites, hormones and other signal molecules (this analysis complements the previous ones by producing a complete description of non-lipid metabolites in breast milk); | On the 21st postpartum day |