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

Not Applicable

Completed

• Conditions: Breast Feeding
• Interventions: 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

• Registration Number: NCT03805997
• Lead Sponsor: Rennes University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-11
• Study First Submitted QC: 2019-01-15
• Study First Posted: 2019-01-16
• Study Start: 2019-04-08
• Primary Completion: 2022-04-22
• Study Completion: 2022-04-22
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	breast milk sample	consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day
Experimental Group	Dietary advice	consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day
Experimental Group	Blood sample	consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day
Experimental Group	newborn faeces sample	consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day
Experimental Group	Consumption of Bleu-Blanc-Coeur products	consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day
Control Group	Dietary advice	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.
Experimental Group	Contact	consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day
Experimental Group	food questionnaire	consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day
Control Group	No consumption of Bleu-Blanc-Coeur products	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.
Control Group	Blood sample	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.
Control Group	food questionnaire	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.
Control Group	newborn faeces sample	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.
Control Group	breast milk sample	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.

Primary Outcome Measures

Name	Time	Method
Level of α-linolenic acid in milk	on the 21st postpartum day.	The primary evaluation criterion is the level of α-linolenic acid in milk on the 21st postpartum day.

Secondary Outcome Measures

Name	Time	Method
The α-linolenic acid level of breast milk	at the 45th postpartum day;	The α-linolenic acid level of breast milk at the 45th postpartum day;
The immunoglobulin A and G content of breast milk	on the 21st and the 45th postpartum days;	The immunoglobulin A and G content of breast milk on the 21st and the 45th postpartum days;
The oligosaccharide content of breast milk	on the 21st and the 45th postpartum days	The oligosaccharide content of breast milk on the 21st and the 45th postpartum days;
The fatty acid content of breast milk ;	on the 21st and the 45th postpartum days	The fatty acid content of breast milk on the 21st and the 45th postpartum days;
The cytokine content of breast milk	on the 21st and the 45th postpartum days	The cytokine content of breast milk on the 21st and the 45th postpartum days: IL-6, TNFα, TGFβ
The breast milk microbiota content	on the 21st and the 45th postpartum days	The breast milk microbiota content on the 21st and the 45th postpartum days;
The lactoferrin content (antimicrobial factor) of breast milk	on the 21st and the 45th postpartum days;	The lactoferrin content (antimicrobial factor) of breast milk on the 21st and the 45th postpartum days;
The hormone content of breast milk	on the 21st and the 45th postpartum days	The hormone content of breast milk on the 21st and the 45th postpartum days: adiponectin, leptin, insulin;
The breast milk lipidome	on the 21st postpartum day	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);
The maternal milk metabolome	On the 21st postpartum day	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);
the bacterial intestinal microbiota content from the feces of the newborn	on the 21st postpartum day;	the bacterial intestinal microbiota content from the feces of the newborn on the 21st postpartum day;
Fatty acid content	before the 7th month of pregnancy and on the 21st postpartum day.	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.

Trial Locations

Locations (1)

CIC CHU de Rennes; 🇫🇷 Rennes, France