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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

Tracking Information
First Submitted Date  ICMJE March 16, 2021
First Posted Date  ICMJE March 18, 2021
Last Update Posted Date January 21, 2022
Actual Study Start Date  ICMJE March 18, 2021
Actual Primary Completion Date December 17, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2021)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2021)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lactation Cookie Study
Official Title  ICMJE The Lactation Cookie Study
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Breastfeeding
Intervention  ICMJE
  • 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.

Study Arms  ICMJE
  • Experimental: Intervention
    Lactation cookies
    Intervention: Other: Lactation cookies
  • Placebo Comparator: Control
    Control cookies
    Intervention: Other: Control cookies
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2021)
176
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 17, 2021
Actual Primary Completion Date December 17, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04805008
Other Study ID Numbers  ICMJE 10036
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Current Responsible Party Ana M. Palacios, Indiana University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Indiana University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE University of Florida
Investigators  ICMJE
Principal Investigator: Ana Palacios, MD, PhD Indiana University Bloomington
Principal Investigator: David Allison, PhD Indiana University Bloomington
PRS Account Indiana University
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP