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

NCT03805997 | Completed

• 1 other identifier: 35RC17_8820
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Breast Feeding

Outcome Measures

Primary Outcomes (1)

• Level of α-linolenic acid in milk

  The primary evaluation criterion is the level of α-linolenic acid in milk on the 21st postpartum day.

  on the 21st postpartum day.

Secondary Outcomes (12)

• The α-linolenic acid level of breast milk

  at the 45th postpartum day;

• The fatty acid content of breast milk ;

  on the 21st and the 45th postpartum days

• The cytokine content of breast milk

  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;

• The lactoferrin content (antimicrobial factor) of breast milk

  on the 21st and the 45th postpartum days;

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Device: Dietary advice; Other: Consumption of Bleu-Blanc-Coeur products; Biological: Blood sample; Other: Contact; Other: food questionnaire; Other: newborn faeces sample; Other: breast milk sample

Control Group

PLACEBO COMPARATOR

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.

Device: Dietary advice; Other: No consumption of Bleu-Blanc-Coeur products; Biological: Blood sample; Other: food questionnaire; Other: newborn faeces sample; Other: breast milk sample

Interventions

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.

Control Group; Experimental Group

Consumption of Bleu-Blanc-Coeur products OTHER

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

Experimental Group

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.

Control Group

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

Control Group; Experimental Group

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.

Experimental Group

food questionnaire OTHER

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

Control Group; Experimental Group

newborn faeces sample OTHER

Newborn faeces sample will be collected at 21 Days post partum

Control Group; Experimental Group

breast milk sample OTHER

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

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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;

You may not qualify if:

• Interruption of breastfeeding before the 21st postpartum day
• Prematurity: childbirth before the 37th week of amenorrhea

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CIC CHU de Rennes

Rennes, 35000, France

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Nutrition Assessment; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 16, 2019
• Study Start: April 8, 2019
• Primary Completion: April 22, 2022
• Study Completion: April 22, 2022
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

FR (1)