Galactagogue Use in Lactating Women With Low Milk Supply

NCT ID: NCT05398367

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-05
• Study Completion Date: 2026-06-01

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.

Conditions

Breast Milk Expression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Oat Mama Lactation Supplement

Participants will receive a 20 day supply of oat mama lactation supplement for consumption per the manufacturer instructions

Group Type: EXPERIMENTAL

Galactagogue Supplement for Treatment of Low Milk Supply

Intervention Type: 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

Participants will receive a 20 day supply of moringa supplement for consumption per the manufacturer instructions

Group Type: EXPERIMENTAL

Galactagogue Supplement for Treatment of Low Milk Supply

Intervention Type: 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

Shatavari Supplement

Participants will receive a 20 day supply of shatavari supplement for consumption per the manufacturer instructions

Group Type: EXPERIMENTAL

Galactagogue Supplement for Treatment of Low Milk Supply

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

Galactagogue Supplement for Treatment of Low Milk Supply

Intervention Type: 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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Winthrop University

OTHER

Sponsor Role: lead

Responsible Party

Hope Lima

Assistant Professor and Graduate Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hope K Lima, PhD

Role: PRINCIPAL_INVESTIGATOR

Winthrop University

Locations

Winthrop University

Rock Hill, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hope K Lima, PhD

Role: CONTACT

limah@winthrop.edu

803-323-4540

Facility Contacts

Hope K Lima, PhD

Role: primary

limah@winthrop.edu

803-323-4540

Other Identifiers

IRB22107R

Identifier Type: -

Identifier Source: org_study_id