Clinical Trials Directory

Trials / Completed

CompletedNCT03805997

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
Phase
N/A
Study type
Interventional
Enrollment
66 (actual)
Sponsor
Rennes University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEDietary adviceparticipants 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 productsconsumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day
OTHERNo consumption of Bleu-Blanc-Coeur productsno 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 samplethe fatty acid profile of the women red blood cells of the woman wil be test at the inclusion and at 21 days post-partum
OTHERContactParticipants 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.
OTHERfood questionnaireParticipants will have to complete a food questionnaire at the inclusion and at 21 days post-partum
OTHERnewborn faeces sampleNewborn faeces sample will be collected at 21 Days post partum
OTHERbreast milk sampleBreast milk sample will be collected at 21 days and 45 days post partum

Timeline

Start date
2019-04-08
Primary completion
2022-04-22
Completion
2022-04-22
First posted
2019-01-16
Last updated
2024-07-31

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03805997. Inclusion in this directory is not an endorsement.