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| Name | Class |
|---|---|
| University of Florida | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Lactation cookies |
|
| Control | Placebo Comparator | Control cookies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactation cookies | Other | 1 serving of 2 OZ of cookies per day for 30 consecutive days. These cookies will contain ingredients thought to increase breast milk production. |
|
| 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 |
| 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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Ana Palacios, MD, PhD | Indiana University, Bloomington | Principal Investigator |
| David Allison, PhD | Indiana University, Bloomington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University - Bloomington | Bloomington | Indiana | 47405 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40754212 | Derived | 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. | |
| 36921902 | Derived |
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Individual participant data related to the analysis and results of the primary and secondary outcomes listed herein will be available after deidentification.
Immediately following publication. No end date.
Anyone who wishes to access the data.
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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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.
| Control cookies | Other | 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. |
|
| 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. |