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

July 30, 2024 updated by: Rennes University Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Rennes, France, 35000
        • CIC CHU de Rennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day
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
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.
Other: food questionnaire
Participants will have to complete a food questionnaire at the inclusion and at 21 days post-partum
Other: newborn faeces sample
Newborn faeces sample will be collected at 21 Days post partum
Other: breast milk sample
Breast milk sample will be collected at 21 days and 45 days post partum
Placebo Comparator: 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.
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.
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: food questionnaire
Participants will have to complete a food questionnaire at the inclusion and at 21 days post-partum
Other: newborn faeces sample
Newborn faeces sample will be collected at 21 Days post partum
Other: breast milk sample
Breast milk sample will be collected at 21 days and 45 days post partum
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
on the 21st postpartum day.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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;
at the 45th postpartum day;
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;
on the 21st and the 45th postpartum days
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
on the 21st and the 45th postpartum days
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;
on the 21st and the 45th postpartum days;
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;
on the 21st and the 45th postpartum days;
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;
on the 21st and the 45th postpartum days
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;
on the 21st and the 45th postpartum days
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;
on the 21st and the 45th postpartum days
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;
on the 21st postpartum day;
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.
before the 7th month of pregnancy and on the 21st postpartum day.
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);
on the 21st postpartum day
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);
On the 21st postpartum day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 22, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 35RC17_8820

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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