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

Rennes University Hospital

Status: Completed

Conditions: Breast Feeding

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03805997

35RC17_8820

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups, including a placebo group

Experimental Group

Experimental group

Description:

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

Treatment:

Other: breast milk sample

Other: Contact

Other: Consumption of Bleu-Blanc-Coeur products

Other: food questionnaire

Biological: Blood sample

Other: newborn faeces sample

Device: Dietary advice

Control Group

Placebo Comparator group

Description:

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.

Treatment:

Other: No consumption of Bleu-Blanc-Coeur products

Other: breast milk sample

Other: food questionnaire

Biological: Blood sample

Other: newborn faeces sample

Device: Dietary advice