Lactation Cookie Study

The Lactation Cookie Study

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.

Study Overview

• Status: Completed
• Conditions: Breastfeeding
• Intervention / Treatment: Other: Lactation cookies; Other: Control cookies

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.

• Study Type: Interventional
• Enrollment (Actual): 176
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Indiana University - Bloomington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Lactation cookies	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.
Placebo Comparator: Control; Control cookies	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in perceived milk supply scores from baseline to 1-month post intervention	Assessed using the McCarter-Spaulding Perceived Insufficient Milk Questionnaire	1 month

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: University of Florida
• Investigators: Principal Investigator: Ana Palacios, MD, PhD, Indiana University Bloomington; Principal Investigator: David Allison, PhD, Indiana University Bloomington

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2021
• Primary Completion (Actual): December 17, 2021
• Study Completion (Actual): December 17, 2021

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 19, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Breastfeeding, lactation cookies, breast milk production
• Other Study ID Numbers: 10036 (DAIDS ES Registry Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data related to the analysis and results of the primary and secondary outcomes listed herein will be available after deidentification.
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Anyone who wishes to access the data.
• IPD Sharing Supporting Information Type: Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No