The Effect of Lactation Cookies on Breastfeeding Outcomes in Lactating Women

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Change in breast milk volume from baseline to 1 month post-intervention [Срок оценки: 1 month]

Вторичные конечные точки (11)

• Change in breastfeeding self-efficacy scores from baseline to 1 month post-intervention [Срок оценки: 1 month]
• Anxiety score changes from baseline to 1-month post intervention [Срок оценки: 1 month]
• Changes in perceived milk supply scores from baseline to 1-month post intervention [Срок оценки: 1 month]
• Changes in postnatal depression scores from baseline to 1-month post intervention [Срок оценки: 1 month]
• Change in infant weight from baseline to 1 month post-intervention [Срок оценки: 1 month]
• Change in infant length from baseline to 1 month post-intervention [Срок оценки: 1 month]
• Change in infant head circumference from baseline to 1 month post-intervention [Срок оценки: 1 month]
• Change in number of wet diapers from baseline to 1 month [Срок оценки: 1 month]
• Change in number of soiled diapers from baseline to 1 month [Срок оценки: 1 month]
• Change in breast milk composition from baseline to 1 month post-intervention [Срок оценки: 1 month]
• Change in infant weight before and after each feed from baseline to 1 month post-intervention [Срок оценки: 1 month]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Другое

Центры проведения

Ливан · 1 центр

• Keserwan Medical Center — Jounieh

Публикации

• 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. PMID 32700964
• 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. PMID 20433368
• 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. PMID 3651732
• 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. PMID 14649593
• 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. PMID 11572532
• 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. PMID 36921902

Идентификаторы

NCT: NCT07030491 · IRB 202425

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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