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NCT Number: NCT05398367

Galactagogue Use in Lactating Women With 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.

Recruiting

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Winthrop University

Rock Hill, South Carolina, 29733, United States

Location status: Recruiting

Location contact

Hope K Lima, PhD

CONTACT

[email protected]

803-323-4540

Hope K Lima, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Galactagogue Supplement for Treatment of Low Milk Supply

Dietary Supplement

Participants will consume a commercially available dietary supplement on the market for augmentation of breast milk production in lactating women with low milk supply

Primary outcomes

  1. Change in Breast Milk Supply

    Time frame: 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

  2. Change in Serum Prolactin

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Hope K Lima, PhD

CONTACT

[email protected]

803-323-4540

Sponsors and collaborators

Lead sponsor

Winthrop University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 1, 2022
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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