CIC CHU de Rennes
Rennes, 35000, France
NCT Number: NCT03805997
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Rennes, 35000, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Non-inclusion criteria:
Exclusion criteria
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.
consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day
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.
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
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
Newborn faeces sample will be collected at 21 Days post partum
Breast milk sample will be collected at 21 days and 45 days post partum
Time frame: on the 21st postpartum day.
The primary evaluation criterion is the level of α-linolenic acid in milk on the 21st postpartum day.
Time frame: at the 45th postpartum day;
The α-linolenic acid level of breast milk at the 45th postpartum day;
Time frame: on the 21st and the 45th postpartum days
The fatty acid content of breast milk on the 21st and the 45th postpartum days;
Time frame: on the 21st and the 45th postpartum days
The cytokine content of breast milk on the 21st and the 45th postpartum days: IL-6, TNFα, TGFβ
Time frame: on the 21st and the 45th postpartum days;
The immunoglobulin A and G content of breast milk on the 21st and the 45th postpartum days;
Time frame: on the 21st and the 45th postpartum days;
The lactoferrin content (antimicrobial factor) of breast milk on the 21st and the 45th postpartum days;
Time frame: on the 21st and the 45th postpartum days
The hormone content of breast milk on the 21st and the 45th postpartum days: adiponectin, leptin, insulin;
Time frame: on the 21st and the 45th postpartum days
The oligosaccharide content of breast milk on the 21st and the 45th postpartum days;
Time frame: on the 21st and the 45th postpartum days
The breast milk microbiota content on the 21st and the 45th postpartum days;
Time frame: on the 21st postpartum day;
the bacterial intestinal microbiota content from the feces of the newborn on the 21st postpartum day;
Time frame: before 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.
Time frame: on the 21st postpartum day
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);
Time frame: On the 21st postpartum day
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);
Rennes University Hospital
Other
Does a Diet With the Recommended Amount of Polyunsaturated Fatty Acids, Increase Their Proportion in Maternal Milk? A Prospective Randomized Open Study
Acronym: ALLAITEMENT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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