Does a Diet With the Recommended Amount of Polyunsaturated Fatty Acids, Increase Their Proportion in Maternal Milk?
NCT ID: NCT03805997
Last Updated: 2024-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
66 participants
INTERVENTIONAL
2019-04-08
2022-04-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Experimental Group
consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day
Dietary 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.
Consumption of Bleu-Blanc-Coeur products
consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day
Blood 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
Contact
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.
food questionnaire
Participants will have to complete a food questionnaire at the inclusion and at 21 days post-partum
newborn faeces sample
Newborn faeces sample will be collected at 21 Days post partum
breast milk sample
Breast milk sample will be collected at 21 days and 45 days post partum
Control Group
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.
Dietary 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.
No 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.
Blood 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
food questionnaire
Participants will have to complete a food questionnaire at the inclusion and at 21 days post-partum
newborn faeces sample
Newborn faeces sample will be collected at 21 Days post partum
breast milk sample
Breast milk sample will be collected at 21 days and 45 days post partum
Interventions
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Dietary 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.
Consumption of Bleu-Blanc-Coeur products
consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day
No 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.
Blood 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
Contact
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.
food questionnaire
Participants will have to complete a food questionnaire at the inclusion and at 21 days post-partum
newborn faeces sample
Newborn faeces sample will be collected at 21 Days post partum
breast milk sample
Breast milk sample will be collected at 21 days and 45 days post partum
Eligibility Criteria
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Inclusion Criteria
* ≤ 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.
* 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
* Prematurity: childbirth before the 37th week of amenorrhea
18 Years
ALL
Yes
Sponsors
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Rennes University Hospital
OTHER
Responsible Party
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Locations
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CIC CHU de Rennes
Rennes, , France
Countries
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Other Identifiers
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35RC17_8820
Identifier Type: -
Identifier Source: org_study_id
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