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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03805997
Acronym
ALLAITEMENT
Enrollment
66
Registered
2019-01-16
Start date
2019-04-08
Completion date
2022-04-22
Last updated
2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Feeding

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.

Interventions

DEVICEDietary 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.

OTHERConsumption of Bleu-Blanc-Coeur products

consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day

OTHERNo 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.

BIOLOGICALBlood 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

OTHERContact

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.

Participants will have to complete a food questionnaire at the inclusion and at 21 days post-partum

OTHERnewborn faeces sample

Newborn faeces sample will be collected at 21 Days post partum

OTHERbreast milk sample

Breast milk sample will be collected at 21 days and 45 days post partum

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Level of α-linolenic acid in milkon the 21st postpartum day.The primary evaluation criterion is the level of α-linolenic acid in milk on the 21st postpartum day.

Secondary

MeasureTime frameDescription
The fatty acid content of breast milk ;on the 21st and the 45th postpartum daysThe fatty acid content of breast milk on the 21st and the 45th postpartum days;
The cytokine content of breast milkon the 21st and the 45th postpartum daysThe cytokine content of breast milk on the 21st and the 45th postpartum days: IL-6, TNFα, TGFβ
The immunoglobulin A and G content of breast milkon 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 lactoferrin content (antimicrobial factor) of breast milkon 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 milkon the 21st and the 45th postpartum daysThe hormone content of breast milk on the 21st and the 45th postpartum days: adiponectin, leptin, insulin;
The α-linolenic acid level of breast milkat the 45th postpartum day;The α-linolenic acid level of breast milk at the 45th postpartum day;
The breast milk microbiota contenton the 21st and the 45th postpartum daysThe breast milk microbiota content on the 21st and the 45th postpartum days;
the bacterial intestinal microbiota content from the feces of the newbornon the 21st postpartum day;the bacterial intestinal microbiota content from the feces of the newborn on the 21st postpartum day;
Fatty acid contentbefore 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.
The breast milk lipidomeon the 21st postpartum daythe 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 metabolomeOn the 21st postpartum daythe 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 oligosaccharide content of breast milkon the 21st and the 45th postpartum daysThe oligosaccharide content of breast milk on the 21st and the 45th postpartum days;

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026