Galactagogue Supplements for Low Milk Supply

Overseen By Hope K Lima, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Winthrop University

Must not be taking: Galactagogues

Disqualifiers: Breast reduction, IVF, age, others

Compensation: Varies

Number of Visits: 3

Duration: 20 days

120 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Moringa, Oat Mama Lactation Supplement, Shatavari, and other components for increasing breast milk supply?

Research shows that Moringa oleifera and Shatavari (Asparagus racemosus) can help increase breast milk production. A study found that women taking Shatavari had a higher milk volume and quicker breast fullness compared to a placebo, while Moringa is noted for its nutrient density and potential to boost milk production. ^{1 2 3 4 5}

Is it safe to use galactagogue supplements like Shatavari and Moringa for increasing breast milk supply?

In a study on Shatavari, no adverse events were noted, suggesting it is generally safe for postpartum women. However, there is limited safety data on herbal galactagogues like Moringa, and they are not regulated by the U.S. Food and Drug Administration. ^{1 2 4 5 6}

How does the treatment with Moringa, Oat Mama Lactation Supplement, and Shatavari differ from other treatments for low milk supply?

This treatment is unique because it combines Moringa, known for its milk-boosting properties, with Shatavari, a traditional Indian herb used to enhance lactation, and Oat Mama Lactation Supplement, which is designed to be palatable and nutritionally rich. Unlike some other treatments, this combination is available in various forms like bars and capsules, making it convenient and potentially more appealing for postpartum women. ^{4 5 6 7 8}

Research Team

Hope K Lima, PhD

Principal Investigator

Winthrop University

Eligibility Criteria

This trial is for breastfeeding women aged 18-39 who feel they have low milk supply and haven't used galactagogues in their current lactation cycle. They must not have had breast reduction surgery, be willing to take a supplement or placebo, provide blood samples, and track milk volume over 20 days.

Inclusion Criteria

Participants must be willing to provide a blood sample at each lactation consult (day 1, 10, 20)

Participants in the study must be struggling with diagnosed or perceived low milk supply

I am willing to measure and report my milk volume on day 1, 10, and 20.

Exclusion Criteria

Consumed galactagogues with the intention of increasing their milk supply during the current lactation cycle

History of utilizing in vitro fertilization

I have had a breast reduction surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Oat Mama Lactation Supplement, moringa, shatavari, or placebo for 20 days

20 days

3 visits (in-person) on day 1, 10, and 20

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Moringa
• Oat Mama Lactation Supplement
• Shatavari

Trial Overview The study tests if Oat Mama Lactation Supplement, moringa, or shatavari can boost milk production by increasing serum prolactin levels compared to a placebo. Participants will use these supplements for 20 days with effects measured through blood tests and milk volume tracking.

Participant Groups

Group I: Shatavari Supplement Experimental Treatment 1 Intervention

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

Group II: Oat Mama Lactation Supplement Experimental Treatment 1 Intervention

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

Group III: Moringa Supplement Experimental Treatment 1 Intervention

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

Group IV: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Winthrop University

Lead Sponsor

Trials

3

Recruited

240+

References

1. United States pubmed.ncbi.nlm.nih.gov

The effect of Moringa oleifera capsule in increasing breastmilk volume in early postpartum patients: A double-blind, randomized controlled trial. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Lactogenic effect of Polyscias scutellaria extract to maintain postpartum prolactin and oxytocin in lactating rats. [2023]

3. England pubmed.ncbi.nlm.nih.gov

The impact of Moringa oleifera leaf supplementation on human and animal nutrition, growth, and milk production: A systematic review. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of Moringa oleifera capsule in increasing breast milk volume in early postpartum patients: A double-blind, randomized controlled trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Postpartum Use of Shavari Bar® Improves Breast Milk Output: A Double-Blind, Prospective, Randomized, Controlled Clinical Study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Galactagogues and Lactation: Considerations for Counseling Breastfeeding Mothers. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

[Use and value of common European lactation-promoting medicinal plants (galactagogues)]. [2006]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical Study on Plant Galactagogue Worldwide in Promoting Women's Lactation: a Scoping Review. [2021]