Lactation Cookie Study
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|ClinicalTrials.gov Identifier: NCT04805008|
Recruitment Status : Completed
First Posted : March 18, 2021
Last Update Posted : January 21, 2022
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||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||176 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
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.
|Official Title:||The Lactation Cookie Study|
|Actual Study Start Date :||March 18, 2021|
|Actual Primary Completion Date :||December 17, 2021|
|Actual Study Completion Date :||December 17, 2021|
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
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.
- Changes in breast milk production from baseline to 1-month post intervention [ Time Frame: 1 month ]Assessed using the Roznowski 3-hour breast milk expression protocol (milk production hourly rate)
- Changes in perceived milk supply scores from baseline to 1-month post intervention [ Time Frame: 1 month ]Assessed using the McCarter-Spaulding Perceived Insufficient Milk Questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04805008
|United States, Indiana|
|Indiana University - Bloomington|
|Bloomington, Indiana, United States, 47405|
|Principal Investigator:||Ana Palacios, MD, PhD||Indiana University Bloomington|
|Principal Investigator:||David Allison, PhD||Indiana University Bloomington|