Lactation Cookie Study
The Lactation Cookie Study
1 other identifier
interventional
176
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2021
CompletedFirst Posted
Study publicly available on registry
March 18, 2021
CompletedStudy Start
First participant enrolled
March 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 2021
CompletedJanuary 21, 2022
January 1, 2022
9 months
March 16, 2021
January 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Changes in perceived milk supply scores from baseline to 1-month post intervention
1 month
Study Arms (2)
Intervention
EXPERIMENTALLactation cookies
Control
PLACEBO COMPARATORControl cookies
Interventions
1 serving of 2 OZ of cookies per day for 30 consecutive days. These cookies will contain ingredients thought to increase breast milk production.
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- University of Floridacollaborator
Study Sites (1)
Indiana University - Bloomington
Bloomington, Indiana, 47405, United States
Related Publications (2)
Palacios AM, Lemas DJ, Young BE, Parker E, Dickinson S, Marshall N, Sullivan KL, Wilt H, Cardel MI, Allison DB. Associations among Human Milk Polyunsaturated Fatty Acids and Infant Sleep Patterns: A Cross-Sectional Study. J Nutr. 2025 Oct;155(10):3426-3433. doi: 10.1016/j.tjnut.2025.07.021. Epub 2025 Aug 5.
PMID: 40754212DERIVEDPalacios AM, Cardel MI, Parker E, Dickinson S, Houin VR, Young B, Allison DB. Effectiveness of lactation cookies on human milk production rates: a randomized controlled trial. Am J Clin Nutr. 2023 May;117(5):1035-1042. doi: 10.1016/j.ajcnut.2023.03.010. Epub 2023 Mar 14.
PMID: 36921902DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ana Palacios, MD, PhD
Indiana University, Bloomington
- PRINCIPAL INVESTIGATOR
David Allison, PhD
Indiana University, Bloomington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- 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.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 16, 2021
First Posted
March 18, 2021
Study Start
March 18, 2021
Primary Completion
December 17, 2021
Study Completion
December 17, 2021
Last Updated
January 21, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP
- Time Frame
- Immediately following publication. No end date.
- Access Criteria
- Anyone who wishes to access the data.
Individual participant data related to the analysis and results of the primary and secondary outcomes listed herein will be available after deidentification.