The Effect of Lactation Cookies on Breastfeeding Outcomes in Lactating Women

N/ANot Yet RecruitingNCT07030491

Notre Dame University - Louaize36 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Interventions

Lactation CookiesOTHER

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.

Control CookiesOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 1 month

Secondary Outcomes

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.

Time frame: 1 month

Anxiety score changes from baseline to 1-month post intervention

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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 1 month

The Effect of Lactation Cookies on Breastfeeding Outcomes in Lactating Women

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts