NCT05398367

Galactagogue Use in Lactating Women With Low Milk Supply

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Winthrop University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-03-05
• Primary completion: 2025-06-01
• Completion: 2026-06-01
• First posted: 2022-06-01
• Last updated: 2025-03-28

Locations

1 site across 1 country: United States