Does a Diet With the Recommended Amount of Polyunsaturated Fatty Acids, Increase Their Proportion… (NCT03805997) | Clinical Trial Compass
CompletedNot Applicable
Does a Diet With the Recommended Amount of Polyunsaturated Fatty Acids, Increase Their Proportion in Maternal Milk?
France66 participantsStarted 2019-04-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.