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| Name | Class |
|---|---|
| Keserwan Medical Center | OTHER |
| Little Melly | INDUSTRY |
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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:
Researchers will compare lactation cookies to regular cookies to see if lactation cookies work better.
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactation Cookies | Experimental | Participants in this group will consume 2 lactation cookies daily for 30 days. |
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| Control Cookies | Placebo Comparator | Participants in this group will consume 2 control cookies (without active ingredients) daily for 30 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month |
| Anxiety score changes from baseline to 1-month post intervention |
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Inclusion Criteria:
Exclusion Criteria:
Biological females
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessy El Hayek, PhD | Contact | +961 9 218 950 | 2848 | jelhayek@ndu.edu.lb |
| Maria Aoun, Msc | Contact | +961 70717124 | mmaoun02@ndu.edu.lb |
| Name | Affiliation | Role |
|---|---|---|
| Jessy El Hayek, PhD | Notre Dame University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keserwan Medical Center | Jounieh | Lebanon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32700964 | Background | 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. | |
| 20433368 | Background |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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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.
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| 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. |
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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. |
| 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 1 month |
| 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. |
| 3651732 | Background | 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. |
| 14649593 | Background | 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. |
| 11572532 | Background | 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. |
| 36921902 | Background | 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. |