Lactation Cookie Study

• Sponsor: Indiana University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04805008
• Collaborator: University of Florida (Other)
• Enrollment: 176
• Location: 1
• Arms: 2
• Actual Duration (Months): 9
• Patients Per Site Per Month: 19.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breastfeeding	Other: Lactation cookies; Other: Control cookies	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 176 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Participants will receive a generic bag of 57+/-1 grams of either lactation cookies or conventional cookies for 30 days. Investigators will be blinded to treatment allocation.
• Primary Purpose: Other
• Official Title: The Lactation Cookie Study
• Actual Study Start Date: Mar 18, 2021
• Actual Primary Completion Date: Dec 17, 2021
• Actual Study Completion Date: Dec 17, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Changes in breast milk production from baseline to 1-month post intervention [1 month]

   Assessed using the Roznowski 3-hour breast milk expression protocol (milk production hourly rate)

Secondary Outcome Measures

1. Changes in perceived milk supply scores from baseline to 1-month post intervention [1 month]

   Assessed using the McCarter-Spaulding Perceived Insufficient Milk Questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University - Bloomington	Bloomington	Indiana	United States	47405

Sponsors and Collaborators

• Indiana University
• University of Florida

Investigators

• Principal Investigator: Ana Palacios, MD, PhD, Indiana University Bloomington
• Principal Investigator: David Allison, PhD, Indiana University Bloomington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ana M. Palacios, Assistant Professor, Indiana University
• ClinicalTrials.gov Identifier: NCT04805008
• Other Study ID Numbers: 10036
• First Posted: Mar 18, 2021
• Last Update Posted: Jan 21, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ana M. Palacios, Assistant Professor, Indiana University: Breastfeeding, lactation cookies, breast milk production

Study Results

No Results Posted as of Jan 21, 2022