Galactagogue Use in Lactating Women with Low Milk Supply

Winthrop University

Status: Enrolling

Conditions: Breast Milk Expression

Treatments: Dietary Supplement: Galactagogue Supplement for Treatment of Low Milk Supply

Study type: Interventional

Funder types: Other

Identifiers

NCT05398367

IRB22107R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

120 participants in 4 patient groups, including a placebo group

Oat Mama Lactation Supplement

Experimental group

Description:

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

Treatment:

Dietary Supplement: Galactagogue Supplement for Treatment of Low Milk Supply

Moringa Supplement

Experimental group

Description:

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

Treatment:

Dietary Supplement: Galactagogue Supplement for Treatment of Low Milk Supply

Shatavari Supplement

Experimental group

Description:

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

Treatment:

Dietary Supplement: Galactagogue Supplement for Treatment of Low Milk Supply

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Galactagogue Supplement for Treatment of Low Milk Supply