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

Breast Feeding Clinical Trial

— ALLAITEMENT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03805997
• Other study ID #: 35RC17_8820
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2020
• Source: Rennes University Hospital
• Contact: Ronan Thibault
• Phone: 0299285405
• Email: ronan.thibault[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Feeding

Intervention

Device:
• 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.

Other:
• 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.

Biological:
• 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

Other:
• 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

Locations

Country	Name	City	State
France	CIC CHU de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of a-linolenic acid in milk	The primary evaluation criterion is the level of a-linolenic acid in milk on the 21st postpartum day.	on the 21st postpartum day.
Secondary	The a-linolenic acid level of breast milk	The a-linolenic acid level of breast milk at the 45th postpartum day;	at the 45th postpartum day;
Secondary	The fatty acid content of breast milk ;	The fatty acid content of breast milk on the 21st and the 45th postpartum days;	on the 21st and the 45th postpartum days
Secondary	The cytokine content of breast milk	The cytokine content of breast milk on the 21st and the 45th postpartum days: IL-6, TNFa, TGFß	on the 21st and the 45th postpartum days
Secondary	The immunoglobulin A and G content of breast milk	The immunoglobulin A and G content of breast milk on the 21st and the 45th postpartum days;	on the 21st and the 45th postpartum days;
Secondary	The lactoferrin content (antimicrobial factor) of breast milk	The lactoferrin content (antimicrobial factor) of breast milk on the 21st and the 45th postpartum days;	on the 21st and the 45th postpartum days;
Secondary	The hormone content of breast milk	The hormone content of breast milk on the 21st and the 45th postpartum days: adiponectin, leptin, insulin;	on the 21st and the 45th postpartum days
Secondary	The oligosaccharide content of breast milk	The oligosaccharide content of breast milk on the 21st and the 45th postpartum days;	on the 21st and the 45th postpartum days
Secondary	The breast milk microbiota content	The breast milk microbiota content on the 21st and the 45th postpartum days;	on the 21st and the 45th postpartum days
Secondary	the bacterial intestinal microbiota content from the feces of the newborn	the bacterial intestinal microbiota content from the feces of the newborn on the 21st postpartum day;	on the 21st postpartum day;
Secondary	Fatty acid content	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.	before the 7th month of pregnancy and on the 21st postpartum day.
Secondary	The breast milk lipidome	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);	on the 21st postpartum day
Secondary	The maternal milk metabolome	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);	On the 21st postpartum day