Protein Requirement During Lactation (NCT03218956) | Clinical Trial Compass
CompletedNot Applicable
Protein Requirement During Lactation
Canada13 participantsStarted 2017-09-30
Plain-language summary
It is well established that a breast-feeding women need more protein in their diet compared to non-lactating women, but how much additional protein is needed remains unclear. There is reason to believe that the current Dietary Reference Intake (DRI) recommendations for breast-feeding women are too low. To gain better understanding, we plan to study healthy breast-feeding women 20 - 45 yrs, between 3 - 5 months lactation and 6 - 8 months lactation. We will use the indicator amino acid oxidation technique (IAAO), which is a modern, quick and safe research method.
Who can participate
Age range
20 Years – 45 Years
Sex
FEMALE
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:
* Healthy lactating women
* With a healthy baby
* Exclusively breast feeding (3 - 5 months) and are partially breast-feeding women (6 - 8 months) - not supplementing with infant formula
Exclusion Criteria:
* Women below 20 yrs or above 45 yrs of age
* Women who are breast-feeding more than one child
* Women who are not exclusively breast feeding (3 - 5 months) and women who are supplementing with infant formula or have not transitioned to solid foods by 6 - 8 months.
* Women not in good health and have a metabolic, neurological, genetic, or immune disorder.
* Women who are claustrophobic (we will place a clear hood, which can easily be removed, over the participants head for approximately 20 min to measure energy expenditure).
* Women who are substance dependent (i.e. alcohol, cigarette, illicit drugs)
* Women who are allergic to eggs and egg protein
* Women who do not have a healthy baby
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.