Galactagogue Use in Lactating Women With Low Milk Supply

Effect of Single Ingredient and Blend Galactagogue Supplements on Increasing Milk Supply in Lactating Women Experiencing Diagnosed or Perceived Low Milk Supply

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Milk Expression
• Intervention / Treatment: Dietary supplement: Galactagogue Supplement for Treatment of Low 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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hope K Lima, PhD; Phone Number: 803-323-4540; Email: limah@winthrop.edu

Study Locations

• United States
  • South Carolina
    • Rock Hill, South Carolina, United States, 29733
      • Recruiting
      • Winthrop University
      • Contact: Hope K Lima, PhD; Phone Number: 803-323-4540; Email: limah@winthrop.edu
      • Principal Investigator: Hope K Lima, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oat Mama Lactation Supplement; Participants will receive a 20 day supply of oat mama lactation supplement for consumption per the manufacturer instructions	Dietary supplement: Galactagogue Supplement for Treatment of Low Milk Supply; Participants will consume a commercially available dietary supplement on the market for augmentation of breast milk production in lactating women with low milk supply
Experimental: Moringa Supplement; Participants will receive a 20 day supply of moringa supplement for consumption per the manufacturer instructions	Dietary supplement: Galactagogue Supplement for Treatment of Low Milk Supply; Participants will consume a commercially available dietary supplement on the market for augmentation of breast milk production in lactating women with low milk supply
Experimental: Shatavari Supplement; Participants will receive a 20 day supply of shatavari supplement for consumption per the manufacturer instructions	Dietary supplement: Galactagogue Supplement for Treatment of Low Milk Supply; Participants will consume a commercially available dietary supplement on the market for augmentation of breast milk production in lactating women with low milk supply
Placebo Comparator: Placebo; Participants will receive a 20 day supply of placebo pills containing a mixture of flour and brown sugar. Participants will consume 2 placebo pills once per day for 20 days.	Dietary supplement: Galactagogue Supplement for Treatment of Low Milk Supply; Participants will consume a commercially available dietary supplement on the market for augmentation of breast milk production in lactating women with low milk supply

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Breast Milk Supply	Change in breast milk supply will be evaluated using 24-hour breast milk expression volume	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 Serum Prolactin	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	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

Collaborators and Investigators

• Sponsor: Winthrop University
• Investigators: Principal Investigator: Hope K Lima, PhD, Winthrop University

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Galactogogues
• Other Study ID Numbers: IRB22107R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There will be no sharing of individual participant data to researchers outside of the experimental team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No