Status:
COMPLETED
Lactation Cookie Study
Lead Sponsor:
Indiana University
Collaborating Sponsors:
University of Florida
Conditions:
Breastfeeding
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
Lactation cookies contain ingredients thought to increase breast milk production. Although these cookies are widely purchased and consumed with the intention to increase breast milk supply, no scienti...
Detailed Description
Caring for an infant is demanding, and breastfeeding can become a stressful experience, particularly if mothers are concerned about their breast milk supply or whether their milk is nutritious enough ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Living in the contiguous continental 48 states in the US
- Mother of a healthy child born at 37 weeks or later from an uncomplicated birth
- Mother must be 18 years old or older
- Infant aged 2-months at enrollment
- Must intend to exclusively breastfeed infant for at least 3 months after birth
- Must have a working weight scale at home
- No formula use in 2 weeks prior to enrollment or plan to use during the study (1 month)
- Must not have any food or cookie ingredient allergies, dislikes, or contraindications to consume cookies
- Intending to bring the child to CDC recommended well-child visits
- Exclusion Criteria
- Previous or current diagnosis of thyroid disease, epilepsy, psychosis, bipolar disorder
- Receiving treatment for depression or anxiety, or medications that may interfere with milk production (e.g. metoclopramide, chlorpromazine, domperidone, medroxyprogesterone, thyroid hormone).
- Substance use disorder
- Formula feeding or consuming other lactation boosting products during the study
- Having eaten lactation cookies in previous two weeks
Exclusion
Key Trial Info
Start Date :
March 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2021
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT04805008
Start Date
March 18 2021
End Date
December 17 2021
Last Update
January 21 2022
Active Locations (1)
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1
Indiana University - Bloomington
Bloomington, Indiana, United States, 47405