Clinical trial NCT05398367: Galactagogue Use in Lactating Women With Low Milk Supply
Official title: Effect of Single Ingredient and Blend Galactagogue Supplements on Increasing Milk Supply in Lactating Women Experiencing Diagnosed or Perceived Low Milk Supply
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Milk Expression
Lead sponsor: Winthrop University
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into one of four treatment groups: Oat Mama Lactation Supplement (O), moringa supplement (M), shatavari supplement (S), or control (C).
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in Breast Milk Supply
timeFrame: 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
measure: Change in Serum Prolactin
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Rock Hill
country: United States
facility: Winthrop University
state: South Carolina
Study officials:
affiliation: Winthrop University
name: Hope K Lima, PhD
role: PRINCIPAL_INVESTIGATOR
References: