Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Breastfeeding
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Masking Description: 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.Primary Purpose: Other

Participation Requirements

Age
Between 18 years and 50 years
Gender
Only males

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 perce...

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.

Tracking Information

NCT #
NCT04805008
Collaborators
University of Florida
Investigators
Principal Investigator: Ana Palacios, MD, PhD Indiana University Bloomington Principal Investigator: David Allison, PhD Indiana University Bloomington