The Effect of Lactation Cookies on Breastfeeding Outcomes: A Pilot Randomized-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in breast milk volume from baseline to 1 month post-intervention
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Lactation Cookies
Participants in this group will consume 2 lactation cookies daily for 30 days.
干预措施: Lactation Cookies (Other)
Control Cookies
Participants in this group will consume 2 control cookies (without active ingredients) daily for 30 days.
干预措施: Control Cookies (Other)
结局指标
主要结局
Change in breast milk volume from baseline to 1 month post-intervention
时间窗: 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.
次要结局
- Change in breastfeeding self-efficacy scores from baseline to 1 month post-intervention(1 month)
- Anxiety score changes from baseline to 1-month post intervention(1 month)
- Changes in perceived milk supply scores from baseline to 1-month post intervention(1 month)
- Changes in postnatal depression scores from baseline to 1-month post intervention(1 month)
- Change in infant weight from baseline to 1 month post-intervention(1 month)
- Change in infant length from baseline to 1 month post-intervention(1 month)
- Change in infant head circumference from baseline to 1 month post-intervention(1 month)
- Change in number of wet diapers from baseline to 1 month(1 month)
- Change in number of soiled diapers from baseline to 1 month(1 month)
- Change in breast milk composition from baseline to 1 month post-intervention(1 month)
- Change in infant weight before and after each feed from baseline to 1 month post-intervention(1 month)