Breast FeedingALLAITEMENTNCT03805997
Does a Diet With the Recommended Amount of Polyunsaturated Fatty Acids, Increase Their Proportion in Maternal Milk?
A study testing Dietary advice, Consumption of Bleu-Blanc-Coeur products and No consumption of Bleu-Blanc-Coeur products in people with Breast Feeding, run by Rennes University Hospital at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding
- What is being tested?
- Dietary advice, Consumption of Bleu-Blanc-Coeur products and No consumption of Bleu-Blanc-Coeur products
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2019to 22 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Show all 14Show fewer
- 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;
Who cannot join
- Interruption of breastfeeding before the 21st postpartum day
- Prematurity: childbirth before the 37th week of amenorrhea
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Breast Feeding
- Being tested
- Dietary advice, Consumption of Bleu-Blanc-Coeur products, No consumption of Bleu-Blanc-Coeur products, Blood sample, Contact
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary adviceDevice
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 productsOther
consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day
No consumption of Bleu-Blanc-Coeur productsOther
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 sampleBiological
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
ContactOther
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 questionnaireOther
Participants will have to complete a food questionnaire at the inclusion and at 21 days post-partum
newborn faeces sampleOther
Newborn faeces sample will be collected at 21 Days post partum
breast milk sampleOther
Breast milk sample will be collected at 21 days and 45 days post partum
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: on the 21st postpartum day.
Secondary outcomes (12)
The α-linolenic acid level of breast milk
The α-linolenic acid level of breast milk at the 45th postpartum day;
Measured: at the 45th postpartum day;
The fatty acid content of breast milk ;
The fatty acid content of breast milk on the 21st and the 45th postpartum days;
Measured: on the 21st and the 45th postpartum days
The cytokine content of breast milk
The cytokine content of breast milk on the 21st and the 45th postpartum days: IL-6, TNFα, TGFβ
Measured: on the 21st and the 45th postpartum days
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;
Measured: on the 21st and the 45th postpartum days;
The lactoferrin content (antimicrobial factor) of breast milk
The lactoferrin content (antimicrobial factor) of breast milk on the 21st and the 45th postpartum days;
Measured: on the 21st and the 45th postpartum days;
The hormone content of breast milk
The hormone content of breast milk on the 21st and the 45th postpartum days: adiponectin, leptin, insulin;
Measured: on the 21st and the 45th postpartum days
The oligosaccharide content of breast milk
The oligosaccharide content of breast milk on the 21st and the 45th postpartum days;
Measured: on the 21st and the 45th postpartum days
The breast milk microbiota content
The breast milk microbiota content on the 21st and the 45th postpartum days;
Measured: on the 21st and the 45th postpartum days
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;
Measured: on the 21st postpartum day;
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.
Measured: before the 7th month of pregnancy and on the 21st postpartum day.
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);
Measured: on the 21st postpartum day
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);
Measured: On the 21st postpartum day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start8 Apr 2019
- Primary completion22 Apr 2022
- Study completion22 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805997
- Sponsor's protocol ID
- 35RC17_8820
- Acronym
- ALLAITEMENT
- Status last verified
- Jul 2024
- First submitted
- 11 Jan 2019
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thibault R, Boudry G, Legrand P, Boquien CY, Mairesse G, Catheline D, Kerhoas N, Guillevic M, Rousseau C, Laine F, Blat S, Le Huerou-Luron I, Le Gall S, Thoulouze L, Alexandre-Gouabau MC, Laviolle B, Goujon JM, Poffo L, Le Page R, Weill P, Chesneau G, Schmitt B. Increased intake of foods providing alpha-linolenic acid modifies nutritional and non-nutritional characteristics of breast milk: a randomized clinical trial. J Nutr. 2026 Aug 17:101787. doi: 10.1016/j.tjnut.2026.101787. Online ahead of print.
PubMed 42607835
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Diet With the Recommended Amount of Polyunsaturated Fatty Acids, Increase Their Proportion in Maternal Milk? A Prospective Randomized Open Study
- ClinicalTrials.gov ID
- NCT03805997
- Acronym / sponsor ID
- ALLAITEMENT / 35RC17_8820
- Conditions
- Breast Feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | 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 sampleconsumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day |
| Control Group | Placebo comparator | Device: Dietary advice, Other: No consumption of Bleu-Blanc-Coeur products, Biological: Blood sample, Other: food questionnaire, Other: newborn faeces sample, Other: breast milk sampleno consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day. This group will receive Système U vouchers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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);
Key exclusion criteria (2 listed)
- Interruption of breastfeeding before the 21st postpartum day
- Prematurity: childbirth before the 37th week of amenorrhea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary adviceparticipants 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. | Device | Control Group, Experimental Group |
| Consumption of Bleu-Blanc-Coeur productsconsumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day | Other | Experimental Group |
| No consumption of Bleu-Blanc-Coeur productsno consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day. This group will receive Système U vouchers. | Other | Control Group |
| Blood samplethe fatty acid profile of the women red blood cells of the woman wil be test at the inclusion and at 21 days post-partum | Biological | Control Group, Experimental Group |
| ContactParticipants 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 | Experimental Group |
| food questionnaireParticipants will have to complete a food questionnaire at the inclusion and at 21 days post-partum | Other | Control Group, Experimental Group |
| newborn faeces sampleNewborn faeces sample will be collected at 21 Days post partum | Other | Control Group, Experimental Group |
| breast milk sampleBreast milk sample will be collected at 21 days and 45 days post partum | Other | Control Group, Experimental Group |
Primary outcome
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.
12 secondary outcomes
The α-linolenic acid level of breast milk
Time frame: at the 45th postpartum day;
The fatty acid content of breast milk ;
Time frame: 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 immunoglobulin A and G content of breast milk
Time frame: 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 hormone content of breast milk
Time frame: 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 breast milk microbiota content
Time frame: 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;
Fatty acid content
Time frame: before the 7th month of pregnancy and on the 21st postpartum day.
The breast milk lipidome
Time frame: on the 21st postpartum day
The maternal milk metabolome
Time frame: On the 21st postpartum day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Derived from this study: PubMed 42607835Thibault R, Boudry G, Legrand P, Boquien CY, Mairesse G, Catheline D, Kerhoas N, Guillevic M, Rousseau C, Laine F, Blat S, Le Huerou-Luron I, Le Gall S, Thoulouze L, Alexandre-Gouabau MC, Laviolle B, Goujon JM, Poffo L, Le Page R, Weill P, Chesneau G, Schmitt B. Increased intake of foods providing alpha-linolenic acid modifies nutritional and non-nutritional characteristics of breast milk: a randomized clinical trial. J Nutr. 2026 Aug 17:101787. doi: 10.1016/j.tjnut.2026.101787. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary advice, Consumption of Bleu-Blanc-Coeur products and No consumption of Bleu-Blanc-Coeur products in people with Breast Feeding, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of α-linolenic acid in milk (time frame: on the 21st postpartum day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03805997, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.