The Lactation Cookie Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Changes in breast milk production from baseline to 1-month post intervention
研究概览
简要总结
Lactation cookies contain ingredients thought to increase breast milk production. Although these cookies are widely purchased and consumed with the intention to increase breast milk supply, no scientific investigation has explored the effects of lactation cookies on human breast milk production.
This study will evaluate the effects of a lactation cookie in breast milk production, relative to cookies without ingredients thought to increase breast milk production in exclusively breastfeeding mothers of healthy, term babies.
详细描述
Caring for an infant is demanding, and breastfeeding can become a stressful experience, particularly if mothers are concerned about their breast milk supply or whether their milk is nutritious enough to meet their infant's nutritional needs.
In the US, research suggests that about 60% of women perceive their breast milk as insufficient to meet their infant's nutritional needs. As a consequence, about one-fourth of women that perceive insufficient milk production wean their infants prematurely.
Lactation cookies contain ingredients thought to increase breast milk production and are widely consumed for this purpose. However, there is no research that has explored the effects of lactation cookies on breast milk supply. To answer this, the investigators plan a randomized controlled trial involving 176 exclusively breastfeeding mothers of 2-month-old infants. Participants will be randomized into "lactation cookies" or "control cookies" (cookies without ingredients thought to increase breast milk production" and will be asked to eat a bag (2 OZ) of cookies per day for 1 month.
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
- Double (Participant, Investigator)
盲法说明
Participants will receive a generic bag of 57+/-1 grams of either lactation cookies or conventional cookies for 30 days.
Investigators will be blinded to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Living in the contiguous continental 48 states in the US
- •Mother of a healthy child born at 37 weeks or later from an uncomplicated birth
- •Mother must be 18 years old or older
- •Infant aged 2-months at enrollment
- •Must intend to exclusively breastfeed infant for at least 3 months after birth
- •Must have a working weight scale at home
- •No formula use in 2 weeks prior to enrollment or plan to use during the study (1 month)
- •Must not have any food or cookie ingredient allergies, dislikes, or contraindications to consume cookies
- •Intending to bring the child to CDC recommended well-child visits
排除标准
- •Previous or current diagnosis of thyroid disease, epilepsy, psychosis, bipolar disorder
- •Receiving treatment for depression or anxiety, or medications that may interfere with milk production (e.g. metoclopramide, chlorpromazine, domperidone, medroxyprogesterone, thyroid hormone).
- •Substance use disorder
- •Formula feeding or consuming other lactation boosting products during the study
- •Having eaten lactation cookies in previous two weeks
研究组 & 干预措施
Intervention
Lactation cookies
干预措施: Lactation cookies (Other)
Control
Control cookies
干预措施: Control cookies (Other)
结局指标
主要结局
Changes in breast milk production from baseline to 1-month post intervention
时间窗: 1 month
Assessed using the Roznowski 3-hour breast milk expression protocol (milk production hourly rate)
次要结局
- Changes in perceived milk supply scores from baseline to 1-month post intervention(1 month)
研究者
Ana M. Palacios
Assistant Professor
Indiana University