The Effect of Lactation Cookies on Breastfeeding Outcomes in Lactating Women

NCT07030491 | Not Yet Recruiting

• 1 other identifier: IRB 202425
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breastfeeding

Keywords

Lactation; Breastfeeding; Galactagogues; Milk production; Randomized controlled trial; Lactation cookies

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month

Secondary Outcomes (11)

• 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

Study Arms (2)

Lactation Cookies

EXPERIMENTAL

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

Other: Lactation Cookies

Control Cookies

PLACEBO COMPARATOR

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

Other: Control Cookies

Interventions

Lactation Cookies OTHER

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.

Lactation Cookies

Control Cookies OTHER

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.

Control Cookies

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Biological females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Notre Dame University - Louaize: lead
• Keserwan Medical Center: collaborator
• Little Melly: collaborator

Study Sites (1)

Keserwan Medical Center

Jounieh, Lebanon

Location

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Jessy El Hayek, PhD

  Notre Dame University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessy El Hayek, PhD

CONTACT

+961 9 218 950; jelhayek@ndu.edu.lb

Maria Aoun, Msc

CONTACT

+961 70717124; mmaoun02@ndu.edu.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of two groups (lactation cookies or control cookies) and will remain in their group for the 30-day intervention period.

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 22, 2025
• Study Start: June 25, 2025
• Primary Completion: September 25, 2025
• Study Completion: September 25, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

LE (1)