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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Feeding
• Intervention / Treatment: Device: Dietary advice; Other: Consumption of Bleu-Blanc-Coeur products; Biological: Blood sample; Other: Contact; Other: food questionnaire; Other: newborn faeces sample; Other: breast milk sample; Other: No consumption of Bleu-Blanc-Coeur products

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35000
    • CIC CHU de Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day	Device: Dietary advice; 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.; Other: Consumption of Bleu-Blanc-Coeur products; consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day; Biological: Blood sample; 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; Other: Contact; 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.; Other: food questionnaire; Participants will have to complete a food questionnaire at the inclusion and at 21 days post-partum; Other: newborn faeces sample; Newborn faeces sample will be collected at 21 Days post partum; Other: breast milk sample; Breast milk sample will be collected at 21 days and 45 days post partum
Placebo Comparator: Control Group; 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; 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.; Biological: Blood sample; 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; Other: food questionnaire; Participants will have to complete a food questionnaire at the inclusion and at 21 days post-partum; Other: newborn faeces sample; Newborn faeces sample will be collected at 21 Days post partum; Other: breast milk sample; Breast milk sample will be collected at 21 days and 45 days post partum; Other: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2019
• Primary Completion (Actual): April 22, 2022
• Study Completion (Actual): April 22, 2022

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: January 15, 2019
• First Posted (Actual): January 16, 2019

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 35RC17_8820

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No