Clinical trial NCT03805997: Does a Diet With the Recommended Amount of Polyunsaturated Fatty Acids, Increase Their Proportion in Maternal Milk?
Official title: Does a Diet With the Recommended Amount of Polyunsaturated Fatty Acids, Increase Their Proportion in Maternal Milk? A Prospective Randomized Open Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Feeding
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Level of α-linolenic acid in milk
timeFrame: on the 21st postpartum day.
Secondary outcomes:
measure: The α-linolenic acid level of breast milk
timeFrame: at the 45th postpartum day;
measure: The fatty acid content of breast milk ;
timeFrame: on the 21st and the 45th postpartum days
measure: The cytokine content of breast milk
timeFrame: on the 21st and the 45th postpartum days
measure: The immunoglobulin A and G content of breast milk
timeFrame: on the 21st and the 45th postpartum days;
measure: The lactoferrin content (antimicrobial factor) of breast milk
timeFrame: on the 21st and the 45th postpartum days;
measure: The hormone content of breast milk
timeFrame: on the 21st and the 45th postpartum days
measure: The oligosaccharide content of breast milk
timeFrame: on the 21st and the 45th postpartum days
measure: The breast milk microbiota content
timeFrame: on the 21st and the 45th postpartum days
measure: the bacterial intestinal microbiota content from the feces of the newborn
timeFrame: on the 21st postpartum day;
measure: Fatty acid content
timeFrame: before the 7th month of pregnancy and on the 21st postpartum day.
measure: The breast milk lipidome
timeFrame: on the 21st postpartum day
measure: The maternal milk metabolome
timeFrame: On the 21st postpartum day
Other outcomes:
Locations:
city: Rennes
country: France
facility: CIC CHU de Rennes
Study officials:
References: