The Effect of Lactation Cookies on Breastfeeding Outcomes in Lactating Women

Notre Dame University - Louaize

Status: Not yet enrolling

Conditions: Breastfeeding

Treatments: Other: Control Cookies; Other: Lactation Cookies

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07030491

IRB 202425

Details and patient eligibility

About

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

Full description

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.

Enrollment: 36 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

Lactation Cookies

Experimental group

Description:

Participants in this group will consume 2 lactation cookies daily for 30 days.

Treatment:

Other: Lactation Cookies

Control Cookies

Placebo Comparator group

Description:

Participants in this group will consume 2 control cookies (without active ingredients) daily for 30 days.

Treatment:

Other: Control Cookies