The Effect of Lactation Cookies on Breastfeeding Outcomes in Lactating Women
NCT ID: NCT07030491
Last Updated: 2025-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
36 participants
INTERVENTIONAL
2025-06-25
2025-09-25
Brief Summary
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* 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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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Lactation Cookies
Participants in this group will consume 2 lactation cookies daily for 30 days.
Lactation Cookies
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
Participants in this group will consume 2 control cookies (without active ingredients) daily for 30 days.
Control Cookies
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.
Interventions
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Lactation Cookies
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
FEMALE
Yes
Sponsors
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Keserwan Medical Center
OTHER
Little Melly
INDUSTRY
Notre Dame University - Louaize
OTHER
Responsible Party
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Principal Investigators
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Jessy El Hayek, PhD
Role: PRINCIPAL_INVESTIGATOR
Notre Dame University
Locations
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Keserwan Medical Center
Jounieh, , Lebanon
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Lai 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.
Cox 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.
Dennis 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.
McCarter-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.
Palacios 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.
Other Identifiers
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IRB 202425
Identifier Type: -
Identifier Source: org_study_id
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