Galactagogue Use in Lactating Women with Low Milk Supply

Not Applicable

Recruiting

• Conditions: Breast Milk Expression

• Registration Number: NCT05398367
• Lead Sponsor: Winthrop University

Brief Summary

This study aims to determine whether a 20-day supplement with either Oat Mama Lactation Supplement, moringa, or shatavari has any impact on milk production through an increase in serum prolactin levels when compared to the placebo group. This data will be used to determine if clinical recommendations can be made for the use of the studied supplements in increasing milk supply.

Detailed Description

This study will be a double-blind randomized control trial where eligible participants will be randomized into one of four treatment groups: Oat Mama Lactation Supplement (O), moringa supplement (M), shatavari supplement (S), or control (C). All participants will receive a supplement or placebo for consumption throughout the 20-day trial period, and all participants will receive support from a lactation consultant once per week to receive appropriate guidance for increasing milk supply. 24-hour milk output will be recorded on day 1, 10, and 20 using either pre- and post-feeding weights, 24-hour pump output, or a combination of both. Additionally, blood samples will be taken on day 1, 10, and 20 and serum will be isolated for later analysis of serum prolactin levels.

Study Timeline

• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-05-25
• Study First Posted: 2022-06-01
• Study Start: 2024-03-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28
• Primary Completion: 2025-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Participants in the study must:

• Be struggling with diagnosed or perceived low milk supply
• Be willing to consume a randomly assigned galactagogue or placebo supplement
• Be willing to provide a blood sample at each lactation consult (day 1, 10, 20)
• Be willing to provide 24-hour expressed milk volume either using pre- and post-feed weights, total pump output, or a combination of both on day 1, 10, and 20

Exclusion Criteria

Participants will be excluded if:

• They have a history of breast reduction
• They have a history of utilizing in vitro fertilization
• They are not a biological female with mammary glands present for producing milk
• They have consumed galactagogues with the intention of increasing their milk supply during the current lactation cycle
• They are under age 18 or above age 39

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Serum Prolactin	Intervention will last 20 days and blood samples will be taken on day 1, 10, am 20 and change in serum prolactin will be measured using a human serum prolactin ELISA kit	Change in serum prolactin levels will be evaluated by taking blood samples on day 1, 10, and 20 and measuring serum prolactin using a human serum prolactin ELISA kit
Change in Breast Milk Supply	Intervention will last 20 days and 24-hour breast milk expression volume will be measured on day 1, 10, and 20 and used to calculate change in 24-hour breast milk expression volume over the trial period	Change in breast milk supply will be evaluated using 24-hour breast milk expression volume

Trial Locations

Locations (1)

Winthrop University; 🇺🇸 Rock Hill, South Carolina, United States