Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
176 participants
INTERVENTIONAL
2021-03-18
2021-12-17
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Investigators will be blinded to treatment allocation.
Study Groups
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Intervention
Lactation cookies
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
Control cookies
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
FEMALE
Yes
Sponsors
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University of Florida
OTHER
Indiana University
OTHER
Responsible Party
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Ana M. Palacios
Assistant Professor
Principal Investigators
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Ana Palacios, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Indiana University, Bloomington
David Allison, PhD
Role: PRINCIPAL_INVESTIGATOR
Indiana University, Bloomington
Locations
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Indiana University - Bloomington
Bloomington, Indiana, United States
Countries
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References
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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 Aug 5:S0022-3166(25)00473-0. doi: 10.1016/j.tjnut.2025.07.021. Online ahead of print.
Palacios 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.
Other Identifiers
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10036
Identifier Type: -
Identifier Source: org_study_id
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