Galactagogue Use in Lactating Women With Low Milk Supply

Breast Milk Expression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05398367
• Other study ID #: IRB22107R
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2024
• Est. completion date: June 1, 2024

Study information

• Verified date: April 2024
• Source: Winthrop University
• Contact: Hope K Lima, PhD
• Phone: 803-323-4540
• Email: limah[@]winthrop.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Milk Expression

Intervention

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

Locations

Country	Name	City	State
United States	Winthrop University	Rock Hill	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Winthrop University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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