Lactation Cookie Study

Completed · Not applicable

Conditions studied: Breastfeeding

In brief

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 scientific investigation has explored the effects of lactation cookies on human breast milk production. This study will evaluate the effects of a lactation cookie in breast milk production, relative to cookies without ingredients thought to increase breast milk production in exclusively breastfeeding mothers of healthy, term babies.

Key facts

Study ID

NCT04805008

Run by

Indiana University

People needed

176

Starts

2021-03-18

Expected to finish

2021-12-17

Last updated by the study team

2022-01-21

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Indiana University - Bloomington — Bloomington, Indiana, United States

Full record on ClinicalTrials.gov

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