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NCT Number: NCT07030491

The Effect of Lactation Cookies on Breastfeeding Outcomes in Lactating Women

The goal of this clinical trial is to learn if eating lactation cookies can help breastfeeding women make more milk. The main questions it aims to answer are:

* Do lactation cookies help increase milk production? * Do lactation cookies make the breastfeeding experience easier or better?

Researchers will compare lactation cookies to regular cookies to see if lactation cookies work better.

Participants will:

* Eat 2 cookies every day for 30 days * Visit the clinic 2 times, at the start and end of the study * Keep a simple record of their breastfeeding and cookie eating

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Keserwan Medical Center

Jounieh, Lebanon

Location contact

Crystal Ghantous, PhD

SUB_INVESTIGATOR

Jessy El Hayek, PhD

PRINCIPAL_INVESTIGATOR

Labiba Dahdah, MPH

CONTACT

[email protected]

+961 9 857300 ext. 7953

Maria Aoun, Msc

PRINCIPAL_INVESTIGATOR

About this study

Lactation cookies are popular among breastfeeding mothers because they often contain certain ingredients, such as fenugreek, ginger, and moringa, that are believed to help increase milk supply. Despite their widespread use, there is limited scientific evidence to confirm whether these cookies effectively increase breast milk volume or improve the breastfeeding experience.

This randomized controlled trial aims to evaluate the effects of lactation cookies on milk production and breastfeeding outcomes among exclusively breastfeeding mothers. Participants will be randomly assigned to consume a total of 2 cookies per day for 30 days; the cookies will either be lactation cookies or control cookies lacking milk-enhancing ingredients. Breast milk volume will be measured at the beginning and end of the study using standardized collection methods. Additional data will be collected to assess breastfeeding experience and any changes in infant feeding patterns.

This study will help clarify whether lactation cookies provide measurable benefits for breastfeeding mothers and their infants. The findings may support breastfeeding women and guide recommendations on the use of dietary galactagogues like lactation cookies.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Women 1 month postpartum
  • Exclusively breastfeeding
  • Aged 18-45 years
  • Healthy term infants (≥37 weeks gestation)
  • Uncomplicated pregnancies and births
  • Residing in Lebanon
  • Planning to exclusively breastfeed for at least 2 months
  • Intending to attend recommended pediatrician visits
  • Infants must be at least 1 month old

Exclusion criteria

  • Twin pregnancy
  • Allergies or dislike of ingredients in the study cookies
  • Presence of any health condition including: thyroid disease, epilepsy, psychosis, or bipolar disorder
  • Currently receiving treatment for depression or anxiety
  • Mastitis
  • Smoking or alcohol consumption
  • Taking medications or substances that may affect milk production, including: metoclopramide, chlorpromazine, domperidone, herbal galactagogues, thyroid hormones, or blood thinning medications

Treatment and study plan

Lactation cookies

Other

Participants will consume 2 cookies per day (approximately 40g daily) for 30 consecutive days. The lactation cookies contain ingredients commonly believed to enhance milk production, including moringa, fenugreek, and ginger.

Control cookies

Other

Participants in the control group will consume 2 cookies per day (approximately 40g total) for 30 consecutive days. These cookies are matched in taste, appearance, and caloric content but do not contain any known galactagogue ingredients.

Primary outcomes

  1. Change in breast milk volume from baseline to 1 month post-intervention

    Time frame: 1 month

    Breast milk volume will be assessed using the 3-hour milk expression protocol developed by Lai et al. (2010). This method involves hourly milk expression sessions over a 3-hour period, during which milk synthesis reaches a steady state, allowing for accurate estimation of the milk production rate.

Secondary outcomes

  1. Change in breastfeeding self-efficacy scores from baseline to 1 month post-intervention

    Time frame: 1 month

    Assessed using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), a 14-item scale with scores ranging from 14 to 70, where higher scores indicate greater breastfeeding confidence.

  2. Anxiety score changes from baseline to 1-month post intervention

    Time frame: 1 month

    Assessed using the State-Trait Anxiety Inventory (STAI), which includes two 20-item scales (State and Trait anxiety) scored 20-80; higher scores indicate higher anxiety levels.

  3. Changes in perceived milk supply scores from baseline to 1-month post intervention

    Time frame: 1 month

    Assessed using the McCarter-Spaulding PIM questionnaire, with scores ranging from 5 to 50, where higher scores indicate greater perceived milk sufficiency.

  4. Changes in postnatal depression scores from baseline to 1-month post intervention

    Time frame: 1 month

    Assessed using the Edinburgh Postnatal Depression Scale (EPDS), a 10-item scale with scores ranging from 0 to 30; higher scores indicate more severe depressive symptoms. Scores ≥13 suggest possible depression

  5. Change in infant weight from baseline to 1 month post-intervention

    Time frame: 1 month

    Infant weight will be measured in kilograms (kg) using a calibrated infant scale by a pediatrician at baseline and after 1 month to assess changes in growth. Weight data will be interpreted using appropriate weight-for-age growth scores based on WHO growth standards.

  6. Change in infant length from baseline to 1 month post-intervention

    Time frame: 1 month

    Infant length will be measured in centimeters (cm) using an infantometer or measuring board by a pediatrician at baseline and after 1 month to assess changes in linear growth. Length data will be interpreted using appropriate length-for-age growth scores based on WHO growth standards.

  7. Change in infant head circumference from baseline to 1 month post-intervention

    Time frame: 1 month

    Infant head circumference will be measured in centimeters (cm) using a non-stretchable measuring tape by a pediatrician at baseline and after 1 month to assess brain growth and development. Head circumference data will be interpreted using appropriate head circumference-for-age growth scores based on WHO growth standards.

  8. Change in number of wet diapers from baseline to 1 month

    Time frame: 1 month

    The number of wet diapers per day will be recorded by the mother using self-reported logs throughout the 1-month intervention period to assess hydration status and feeding adequacy.

  9. Change in number of soiled diapers from baseline to 1 month

    Time frame: 1 month

    The number of soiled diapers per day will be recorded by the mother using self-reported logs throughout the 1-month intervention period to assess digestive health and feeding adequacy.

  10. Change in breast milk composition from baseline to 1 month post-intervention

    Time frame: 1 month

    A 15 milliliter (mL) sample of breast milk will be collected from the mother at baseline and after 1 month to assess changes in milk composition. Analyses will focus on nutrient content and the potential transfer of bioactive components from the lactation cookies, including macronutrients (grams per liter, g/L), omega-3 fatty acids (milligrams per deciliter, mg/dL), and other relevant biomarkers.

  11. Change in infant weight before and after each feed from baseline to 1 month post-intervention

    Time frame: 1 month

    Infant weight will be measured in kilograms (kg) using a calibrated infant scale immediately before and after each feeding session at baseline and later on Day 30. The difference between pre- and post-feed weights will be calculated to estimate milk intake per feed.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessy El Hayek, PhD

CONTACT

[email protected]

+961 9 218 950 ext. 2848

Maria Aoun, Msc

CONTACT

[email protected]

+961 70717124

Sponsors and collaborators

Lead sponsor

Notre Dame University - Louaize

Other

Collaborators

  • Keserwan Medical Center
  • Little Melly

Registry information

Official study title

The Effect of Lactation Cookies on Breastfeeding Outcomes: A Pilot Randomized-Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 22, 2025
Registry last updated
Jun 22, 2025

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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