NCT04805008

Lactation Cookie Study

The Lactation Cookie Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Breastfeeding

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2021-03-18
• Primary completion: 2021-12-17
• Completion: 2021-12-17
• First posted: 2021-03-18
• Last updated: 2022-01-21

Locations

1 site across 1 country: United States