Indiana University - Bloomington
Bloomington, Indiana, 47405, United States
NCT Number: NCT04805008
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.
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Notify Me18 year–50 year
Female
Interventional
Not applicable
Bloomington, Indiana, 47405, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 1 month
Assessed using the Roznowski 3-hour breast milk expression protocol (milk production hourly rate)
Time frame: 1 month
Assessed using the McCarter-Spaulding Perceived Insufficient Milk Questionnaire
Indiana University
Other
The Lactation Cookie Study
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