BreastfeedingNCT07030491
The Effect of Lactation Cookies on Breastfeeding Outcomes in Lactating Women
A study testing Lactation Cookies in people with Breastfeeding, run by Notre Dame University - Louaize at 1 site in Lebanon.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Lactation Cookies
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteLebanon
- Study dates
- 25 Jun 2025to 25 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women 1 month postpartum
- Exclusively breastfeeding
- Aged 18-45 years
- Healthy term infants (≥37 weeks gestation)
- Uncomplicated pregnancies and births
- Residing in Lebanon
Show all 9Show fewer
- Planning to exclusively breastfeed for at least 2 months
- Intending to attend recommended pediatrician visits
- Infants must be at least 1 month old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lebanon1 site
Keserwan Medical Center
Jounieh
Labiba Dahdah, MPH, +961 9 857300 ext. 7953, ld01@kmc.com.lb
Jessy El Hayek, PhD
About this study
Official title: The Effect of Lactation Cookies on Breastfeeding Outcomes: A Pilot Randomized-Controlled Trial
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
Read the detailed description
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.
- Conditions
- Breastfeeding
- Being tested
- Lactation Cookies, Control Cookies
- Keywords
- Lactation, Breastfeeding, Galactagogues, Milk production, Randomized controlled trial, Lactation cookies
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactation CookiesOther
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 CookiesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Lactation Cookies | Experimental | Participants in this group will consume 2 lactation cookies daily for 30 days. Receives: Other: Lactation Cookies |
| Control Cookies | Placebo comparator | Participants in this group will consume 2 control cookies (without active ingredients) daily for 30 days. Receives: Other: Control Cookies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in breast milk volume from baseline to 1 month post-intervention
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.
Measured: 1 month
Secondary outcomes (11)
Change in breastfeeding self-efficacy scores from baseline to 1 month post-intervention
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.
Measured: 1 month
Anxiety score changes from baseline to 1-month post intervention
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.
Measured: 1 month
Changes in perceived milk supply scores from baseline to 1-month post intervention
Assessed using the McCarter-Spaulding PIM questionnaire, with scores ranging from 5 to 50, where higher scores indicate greater perceived milk sufficiency.
Measured: 1 month
Changes in postnatal depression scores from baseline to 1-month post intervention
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
Measured: 1 month
Change in infant weight from baseline to 1 month post-intervention
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.
Measured: 1 month
Change in infant length from baseline to 1 month post-intervention
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.
Measured: 1 month
Change in infant head circumference from baseline to 1 month post-intervention
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.
Measured: 1 month
Change in number of wet diapers from baseline to 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.
Measured: 1 month
Change in number of soiled diapers from baseline to 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.
Measured: 1 month
Change in breast milk composition from baseline to 1 month post-intervention
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.
Measured: 1 month
Change in infant weight before and after each feed from baseline to 1 month post-intervention
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start25 Jun 2025 (estimated)
- Primary completion25 Sep 2025 (estimated)
- Study completion25 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two groups (lactation cookies or control cookies) and will remain in their group for the 30-day intervention period.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Notre Dame University - Louaize
- Sponsor type
- University, hospital or other
- Collaborators
- Keserwan Medical Center, Little Melly
- Responsible party
- Sponsor
- Investigators
- Jessy El Hayek, PhD, Principal investigator, Notre Dame University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030491
- Sponsor's protocol ID
- IRB 202425
- Status last verified
- Jun 2025
- First submitted
- 29 May 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Roznowski DM, Wagner EA, Riddle SW, Nommsen-Rivers LA. Validity of a 3-Hour Breast Milk Expression Protocol in Estimating Current Maternal Milk Production Capacity and Infant Breast Milk Intake in Exclusively Breastfeeding Dyads. Breastfeed Med. 2020 Oct;15(10):630-638. doi: 10.1089/bfm.2019.0182. Epub 2020 Jul 16.
PubMed 32700964Lai CT, Hale TW, Simmer K, Hartmann PE. Measuring milk synthesis in breastfeeding mothers. Breastfeed Med. 2010 Jun;5(3):103-7. doi: 10.1089/bfm.2009.0074.
PubMed 20433368Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
PubMed 3651732Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459.
PubMed 14649593McCarter-Spaulding DE, Kearney MH. Parenting self-efficacy and perception of insufficient breast milk. J Obstet Gynecol Neonatal Nurs. 2001 Sep-Oct;30(5):515-22. doi: 10.1111/j.1552-6909.2001.tb01571.x.
PubMed 11572532Palacios AM, Cardel MI, Parker E, Dickinson S, Houin VR, Young B, Allison DB. Effectiveness of lactation cookies on human milk production rates: a randomized controlled trial. Am J Clin Nutr. 2023 May;117(5):1035-1042. doi: 10.1016/j.ajcnut.2023.03.010. Epub 2023 Mar 14.
PubMed 36921902
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lactation Cookies on Breastfeeding Outcomes: A Pilot Randomized-Controlled Trial
- ClinicalTrials.gov ID
- NCT07030491
- Acronym / sponsor ID
- IRB 202425
- Conditions
- Breastfeeding
- Keywords
- Lactation, Breastfeeding, Galactagogues, Milk production, Randomized controlled trial, Lactation cookies
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Notre Dame University - LouaizeUniversity, hospital or other
- Collaborators
- Keserwan Medical Center, Little Melly
- Study start
- 25 Jun 2025 (estimated)
- Primary completion
- 25 Sep 2025 (estimated)
- Study completion
- 25 Sep 2025 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two groups (lactation cookies or control cookies) and will remain in their group for the 30-day intervention period.
| Arm | Type | Receives |
|---|---|---|
| Lactation Cookies | Experimental | Other: Lactation CookiesParticipants in this group will consume 2 lactation cookies daily for 30 days. |
| Control Cookies | Placebo comparator | Other: Control CookiesParticipants in this group will consume 2 control cookies (without active ingredients) daily for 30 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Women 1 month postpartum
- Exclusively breastfeeding
- Aged 18-45 years
- Healthy term infants (≥37 weeks gestation)
- Uncomplicated pregnancies and births
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactation CookiesParticipants 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. | Other | Lactation Cookies |
| Control CookiesParticipants 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. | Other | Control Cookies |
Primary outcome
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.
11 secondary outcomes
Change in breastfeeding self-efficacy scores from baseline to 1 month post-intervention
Time frame: 1 month
Anxiety score changes from baseline to 1-month post intervention
Time frame: 1 month
Changes in perceived milk supply scores from baseline to 1-month post intervention
Time frame: 1 month
Changes in postnatal depression scores from baseline to 1-month post intervention
Time frame: 1 month
Change in infant weight from baseline to 1 month post-intervention
Time frame: 1 month
Change in infant length from baseline to 1 month post-intervention
Time frame: 1 month
Change in infant head circumference from baseline to 1 month post-intervention
Time frame: 1 month
Change in number of wet diapers from baseline to 1 month
Time frame: 1 month
Change in number of soiled diapers from baseline to 1 month
Time frame: 1 month
Change in breast milk composition from baseline to 1 month post-intervention
Time frame: 1 month
Change in infant weight before and after each feed from baseline to 1 month post-intervention
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Background: PubMed 32700964Roznowski DM, Wagner EA, Riddle SW, Nommsen-Rivers LA. Validity of a 3-Hour Breast Milk Expression Protocol in Estimating Current Maternal Milk Production Capacity and Infant Breast Milk Intake in Exclusively Breastfeeding Dyads. Breastfeed Med. 2020 Oct;15(10):630-638. doi: 10.1089/bfm.2019.0182. Epub 2020 Jul 16.
- Background: PubMed 20433368Lai CT, Hale TW, Simmer K, Hartmann PE. Measuring milk synthesis in breastfeeding mothers. Breastfeed Med. 2010 Jun;5(3):103-7. doi: 10.1089/bfm.2009.0074.
- Background: PubMed 3651732Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
- Background: PubMed 14649593Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459.
- Background: PubMed 11572532McCarter-Spaulding DE, Kearney MH. Parenting self-efficacy and perception of insufficient breast milk. J Obstet Gynecol Neonatal Nurs. 2001 Sep-Oct;30(5):515-22. doi: 10.1111/j.1552-6909.2001.tb01571.x.
- Background: PubMed 36921902Palacios AM, Cardel MI, Parker E, Dickinson S, Houin VR, Young B, Allison DB. Effectiveness of lactation cookies on human milk production rates: a randomized controlled trial. Am J Clin Nutr. 2023 May;117(5):1035-1042. doi: 10.1016/j.ajcnut.2023.03.010. Epub 2023 Mar 14.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessy El Hayek, PhD principal investigator
Notre Dame University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactation Cookies in people with Breastfeeding, run by Notre Dame University - Louaize at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessy El Hayek, PhD (+961 9 218 950 ext. 2848, jelhayek@ndu.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in breast milk volume from baseline to 1 month post-intervention (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07030491, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.