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Completed

NCT Number: NCT03805997

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CIC CHU de Rennes

Rennes, 35000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary advice

Device

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

Other

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

No consumption of Bleu-Blanc-Coeur products

Other

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

Biological

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

Other

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

Other

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

newborn faeces sample

Other

Newborn faeces sample will be collected at 21 Days post partum

breast milk sample

Other

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

Primary outcomes

  1. Level of α-linolenic acid in milk

    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.

Secondary outcomes

  1. The α-linolenic acid level of breast milk

    Time frame: at the 45th postpartum day;

    The α-linolenic acid level of breast milk at the 45th postpartum day;

  2. The fatty acid content of breast milk ;

    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;

  3. The cytokine content of breast milk

    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

  4. The immunoglobulin A and G content of breast milk

    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;

  5. The lactoferrin content (antimicrobial factor) of breast milk

    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;

  6. The hormone content of breast milk

    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;

  7. The oligosaccharide content of breast milk

    Time frame: on the 21st and the 45th postpartum days

    The oligosaccharide content of breast milk on the 21st and the 45th postpartum days;

  8. The breast milk microbiota content

    Time frame: on the 21st and the 45th postpartum days

    The breast milk microbiota content on the 21st and the 45th postpartum days;

  9. the bacterial intestinal microbiota content from the feces of the newborn

    Time frame: on the 21st postpartum day;

    the bacterial intestinal microbiota content from the feces of the newborn on the 21st postpartum day;

  10. Fatty acid content

    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.

  11. The breast milk lipidome

    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);

  12. The maternal milk metabolome

    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);

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: ALLAITEMENT

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 16, 2019
Registry last updated
Jul 31, 2024

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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