Galactagogue Use in Lactating Women With Low Milk Supply

NCT05398367 | Recruiting

• 1 other identifier: IRB22107R
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Milk Expression

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Oat Mama Lactation Supplement

EXPERIMENTAL

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

Moringa Supplement

EXPERIMENTAL

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

Shatavari Supplement

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

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

Moringa Supplement; Oat Mama Lactation Supplement; Placebo; Shatavari Supplement

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Lactating women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify 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

Sponsors & Collaborators

• Winthrop University: lead

Study Sites (1)

Winthrop University

Rock Hill, South Carolina, 29733, United States

RECRUITING

MeSH Terms

Conditions

Breast Milk Expression

Condition Hierarchy (Ancestors)

Breast Feeding; Feeding Behavior; Behavior

Study Officials

• Hope K Lima, PhD

  Winthrop University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hope K Lima, PhD

CONTACT

803-323-4540; limah@winthrop.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind randomized controlled trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and Graduate Director

Model Details: Participants will be randomized into one of four treatment groups: Oat Mama Lactation Supplement (O), moringa supplement (M), shatavari supplement (S), or control (C).

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 1, 2022
• Study Start: March 5, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)