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NCT05398367NARecruitingAccepts Healthy Volunteers

Galactagogue Use in Lactating Women With Low Milk Supply

Winthrop University

Start Date

3/5/2024

Completion Date

6/1/2026

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.

Eligibility Criteria

Age Range: 18 years to 40 years

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

Interventions

DIETARY_SUPPLEMENT

Galactagogue Supplement for Treatment of Low Milk Supply

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Conditions

Breast Milk Expression

Locations

Winthrop University

Rock Hill, South Carolina 29733

United States