Clinical trial NCT04805008: Lactation Cookie Study
Official title: The Lactation Cookie Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: Breastfeeding, lactation cookies, breast milk production
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: University of Florida
First posted: 2021-03-18
Enrollment: 176
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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.

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 to meet their infant's nutritional needs.

In the US, research suggests that about 60% of women perceive their breast milk as insufficient to meet their infant's nutritional needs. As a consequence, about one-fourth of women that perceive insufficient milk production wean their infants prematurely.

Lactation cookies contain ingredients thought to increase breast milk production and are widely consumed for this purpose. However, there is no research that has explored the effects of lactation cookies on breast milk supply. To answer this, the investigators plan a randomized controlled trial involving 176 exclusively breastfeeding mothers of 2-month-old infants. Participants will be randomized into "lactation cookies" or "control cookies" (cookies without ingredients thought to increase breast milk production" and will be asked to eat a bag (2 OZ) of cookies per day for 1 month.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in breast milk production from baseline to 1-month post intervention
timeFrame: 1 month
Secondary outcomes:
measure: Changes in perceived milk supply scores from baseline to 1-month post intervention
timeFrame: 1 month
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Indiana University - Bloomington
state: Indiana
Study officials:
affiliation: Indiana University, Bloomington
name: Ana Palacios, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University, Bloomington
name: David Allison, PhD
role: PRINCIPAL_INVESTIGATOR
References: