Lactation Cookie Study

Breastfeeding Clinical Trial

Official title:

The Lactation Cookie Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04805008
• Other study ID #: 10036
• Status: Completed
• Phase: N/A
• Start date: March 18, 2021
• Est. completion date: December 17, 2021

Study information

• Verified date: January 2022
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: December 17, 2021
• Est. primary completion date: December 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Other:
• Lactation cookies
1 serving of 2 OZ of cookies per day for 30 consecutive days. These cookies will contain ingredients thought to increase breast milk production.
• Control cookies
1 serving of 2 OZ of cookies per day for 30 consecutive days. The cookies will not contain ingredients thought to increase breast milk production.

Locations

Country	Name	City	State
United States	Indiana University - Bloomington	Bloomington	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in breast milk production from baseline to 1-month post intervention	Assessed using the Roznowski 3-hour breast milk expression protocol (milk production hourly rate)	1 month
Secondary	Changes in perceived milk supply scores from baseline to 1-month post intervention	Assessed using the McCarter-Spaulding Perceived Insufficient Milk Questionnaire	1 month