Lactation Cookie Study
Last updated on July 2021Recruitment
- 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