Lactation Cookie Study
The Lactation Cookie Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
-
Bloomington, Indiana, United States, 47405
- Indiana University - Bloomington
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Living in the contiguous continental 48 states in the US
- Mother of a healthy child born at 37 weeks or later from an uncomplicated birth
- Mother must be 18 years old or older
- Infant aged 2-months at enrollment
- Must intend to exclusively breastfeed infant for at least 3 months after birth
- Must have a working weight scale at home
- No formula use in 2 weeks prior to enrollment or plan to use during the study (1 month)
- Must not have any food or cookie ingredient allergies, dislikes, or contraindications to consume cookies
- Intending to bring the child to CDC recommended well-child visits
Exclusion Criteria
- Previous or current diagnosis of thyroid disease, epilepsy, psychosis, bipolar disorder
- Receiving treatment for depression or anxiety, or medications that may interfere with milk production (e.g. metoclopramide, chlorpromazine, domperidone, medroxyprogesterone, thyroid hormone).
- Substance use disorder
- Formula feeding or consuming other lactation boosting products during the study
- Having eaten lactation cookies in previous two weeks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
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
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ana Palacios, MD, PhD, Indiana University Bloomington
- Principal Investigator: David Allison, PhD, Indiana University Bloomington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 10036 (DAIDS ES Registry Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.