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Completed

NCT Number: NCT04805008

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University - Bloomington

Bloomington, Indiana, 47405, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactation cookies

Other

1 serving of 2 OZ of cookies per day for 30 consecutive days. These cookies will contain ingredients thought to increase breast milk production.

Control cookies

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • University of Florida

Registry information

Official study title

The Lactation Cookie Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 18, 2021
Registry last updated
Jan 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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