Galactagogue Use in Lactating Women With Low Milk Supply

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Milk Expression

Intervention / Treatment
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* Dietary Supplement: Galactagogue Supplement for Treatment of Low Milk Supply


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oat Mama Lactation Supplement<br>Participants will receive a 20 day supply of oat mama lactation supplement for consumption per the manufacturer instructions | Dietary Supplement: Galactagogue Supplement for Treatment of Low Milk Supply<br>* Participants will consume a commercially available dietary supplement on the market for augmentation of breast milk production in lactating women with low milk supply<br>|
| Experimental: Moringa Supplement<br>Participants will receive a 20 day supply of moringa supplement for consumption per the manufacturer instructions | Dietary Supplement: Galactagogue Supplement for Treatment of Low Milk Supply<br>* Participants will consume a commercially available dietary supplement on the market for augmentation of breast milk production in lactating women with low milk supply<br>|
| Experimental: Shatavari Supplement<br>Participants will receive a 20 day supply of shatavari supplement for consumption per the manufacturer instructions | Dietary Supplement: Galactagogue Supplement for Treatment of Low Milk Supply<br>* Participants will consume a commercially available dietary supplement on the market for augmentation of breast milk production in lactating women with low milk supply<br>|
| Placebo Comparator: Placebo<br>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. | Dietary Supplement: Galactagogue Supplement for Treatment of Low Milk Supply<br>* Participants will consume a commercially available dietary supplement on the market for augmentation of breast milk production in lactating women with low milk supply<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Breast Milk Supply | Change in breast milk supply will be evaluated using 24-hour breast milk expression volume | 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 | 
| Change in Serum Prolactin | Change in serum prolactin levels will be evaluated by taking blood samples on day 1, 10, and 20 and measuring serum prolactin using a human serum prolactin ELISA kit | 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 |