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Lactation Cookie Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04805008
Recruitment Status : Completed
First Posted : March 18, 2021
Last Update Posted : January 21, 2022
Sponsor:
Collaborator:
University of Florida
Information provided by (Responsible Party):
Ana M. Palacios, Indiana University

Brief 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.


Condition or disease Intervention/treatment Phase
Breastfeeding Other: Lactation cookies Other: Control cookies Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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
Official Title: The Lactation Cookie Study
Actual Study Start Date : March 18, 2021
Actual Primary Completion Date : December 17, 2021
Actual Study Completion Date : December 17, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
Experimental: Intervention
Lactation cookies
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.

Placebo Comparator: Control
Control cookies
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.





Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04805008


Locations
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United States, Indiana
Indiana University - Bloomington
Bloomington, Indiana, United States, 47405
Sponsors and Collaborators
Indiana University
University of Florida
Investigators
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Principal Investigator: Ana Palacios, MD, PhD Indiana University Bloomington
Principal Investigator: David Allison, PhD Indiana University Bloomington
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Responsible Party: Ana M. Palacios, Assistant Professor, Indiana University
ClinicalTrials.gov Identifier: NCT04805008    
Other Study ID Numbers: 10036
First Posted: March 18, 2021    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data related to the analysis and results of the primary and secondary outcomes listed herein will be available after deidentification.
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Immediately following publication. No end date.
Access Criteria: Anyone who wishes to access the data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ana M. Palacios, Indiana University:
Breastfeeding, lactation cookies, breast milk production