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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether certain supplements—Moringa, Oat Mama, or Shatavari (also known as Asparagus racemosus)—can increase milk supply by boosting prolactin levels, a hormone that aids in breast milk production. Participants will receive one of these supplements or a placebo for 20 days. The goal is to determine if these supplements can be recommended to improve milk production. The trial seeks individuals who feel they have low milk supply and are willing to try a supplement or placebo, provide blood samples, and measure milk output over 20 days. As an unphased trial, this study offers a unique opportunity to explore new methods for enhancing milk production.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that moringa is usually safe and can help increase milk production. However, it may affect blood clotting, so caution is advised. Some studies have found that moringa can boost milk supply and raise prolactin levels, which may support breastfeeding.

Specific safety data for the Oat Mama Lactation Supplement is not available. However, it contains ingredients like alfalfa and fennel, traditionally used to enhance milk supply and generally considered safe for most people.

Shatavari is another supplement thought to be safe for increasing milk supply in new mothers. However, concerns exist about its use during pregnancy due to potential risks to the baby.

Overall, these supplements are usually well-tolerated, but individual responses can vary. Consulting a healthcare provider before starting any new treatment is advisable, especially for those with health conditions or taking other medications. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Galactagogue supplements like Moringa, Oat Mama Lactation Supplement, and Shatavari are unique because they rely on natural ingredients to potentially boost milk supply in lactating mothers. Unlike pharmaceutical options, which often involve synthetic compounds, these supplements use plant-based components that may offer a gentler approach. Moringa is packed with nutrients that support lactation, Oat Mama is formulated with oats known for their traditional use in milk production, and Shatavari is an Ayurvedic herb believed to enhance milk flow and reproductive health. Researchers are excited because these treatments might offer a more holistic, less invasive way to address low milk supply, which could be more appealing to those seeking natural alternatives.

What evidence suggests that this trial's treatments could be effective for increasing milk supply?

This trial will compare the effects of different galactagogue supplements on milk supply. Research has shown that Moringa oleifera, which participants may receive, might increase milk production by boosting both milk volume and prolactin levels, crucial for milk supply. In contrast, Oat Mama Lactation Supplements, another option in this trial, lack strong evidence of effectiveness; some mothers try them, but studies have not confirmed their impact on milk production. Shatavari, also tested in this trial, appears promising, reportedly increasing milk output and achieving breast fullness faster. Overall, Moringa and Shatavari have more supportive research than Oat Mama for improving milk supply. ^{1 2 3 4 6}

Who Is on the Research Team?

Hope K Lima, PhD

Principal Investigator

Winthrop University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2590161322000321

The effect of Moringa oleifera capsule in increasing breast ... The exclusive breastfeeding rate at 6 months in this study was 52.3% in the Moringa oleifera group, which met the goals set by the World Health Organization.

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK501899/

Moringa - Drugs and Lactation Database (LactMed®) - NCBI ... poor quality. Meta-analyses of small studies indicate that Moringa increases serum prolactin and milk volume and quality.[3–5] A reasonably ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12294722/

Moringa oleifera Supplementation as a Natural Galactagogue Moringa oleifera leaf supplementation appears to enhance lactation by increasing milk volume and prolactin levels in postpartum mothers. However ...

4. mdpi.com mdpi.com/2304-8158/14/14/2487/review_report

A Systematic Review on Its Role in Supporting Milk Volume ... This study explores the effectiveness of Moringa oleifera leaf supplementation as a natural galactagogue for improving lactation outcomes in postpartum mothers.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2475299125030306

Effect of Maternal Moringa oleifera Leaf Supplementation ... In this population, 3 months of maternal moringa consumption was associated with increased expressed milk output and higher circulating infant ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05398367

Galactagogue Use in Lactating Women With Low Milk Supply 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 ...