Breast Milk ExpressionNCT05398367
Galactagogue Use in Lactating Women With Low Milk Supply
A study testing Galactagogue Supplement for Treatment of Low Milk Supply in people with Breast Milk Expression, run by Winthrop University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Milk Expression
- What is being tested?
- Galactagogue Supplement for Treatment of Low Milk Supply
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Winthrop University
Rock Hill, South Carolina, 29733
Hope K Lima, PhD, 803-323-4540, limah@winthrop.edu
Hope K Lima, PhD
About this study
Official title: Effect of Single Ingredient and Blend Galactagogue Supplements on Increasing Milk Supply in Lactating Women Experiencing Diagnosed or Perceived 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 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.
Read the 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.
- Conditions
- Breast Milk Expression
- Being tested
- Galactagogue Supplement for Treatment of Low Milk Supply
- Medical subject headings
- Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galactagogue Supplement for Treatment of Low Milk SupplyDietary supplement
Participants will consume a commercially available dietary supplement on the market for augmentation of breast milk production in lactating women with low milk supply
| Study group | Role | What they receive |
|---|---|---|
| Oat Mama Lactation Supplement | Experimental | Participants will receive a 20 day supply of oat mama lactation supplement for consumption per the manufacturer instructions Receives: Dietary Supplement: Galactagogue Supplement for Treatment of Low Milk Supply |
| Moringa Supplement | Experimental | Participants will receive a 20 day supply of moringa supplement for consumption per the manufacturer instructions Receives: Dietary Supplement: Galactagogue Supplement for Treatment of Low Milk Supply |
| Shatavari Supplement | Experimental | Participants will receive a 20 day supply of shatavari supplement for consumption per the manufacturer instructions Receives: Dietary Supplement: Galactagogue Supplement for Treatment of Low Milk Supply |
| Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Galactagogue Supplement for Treatment of Low Milk Supply |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Breast Milk Supply
Change in breast milk supply will be evaluated using 24-hour breast milk expression volume
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start5 Mar 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Milk ExpressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Winthrop University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hope Lima, Winthrop University
- Investigators
- Hope K Lima, PhD, Principal investigator, Winthrop University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398367
- Sponsor's protocol ID
- IRB22107R
- Status last verified
- Mar 2025
- First submitted
- 23 May 2022
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There will be no sharing of individual participant data to researchers outside of the experimental team.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Single Ingredient and Blend Galactagogue Supplements on Increasing Milk Supply in Lactating Women Experiencing Diagnosed or Perceived Low Milk Supply
- ClinicalTrials.gov ID
- NCT05398367
- Acronym / sponsor ID
- IRB22107R
- Conditions
- Breast Milk Expression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Winthrop UniversityUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- 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).
| Arm | Type | Receives |
|---|---|---|
| Oat Mama Lactation Supplement | Experimental | Dietary Supplement: Galactagogue Supplement for Treatment of Low Milk SupplyParticipants will receive a 20 day supply of oat mama lactation supplement for consumption per the manufacturer instructions |
| Moringa Supplement | Experimental | Dietary Supplement: Galactagogue Supplement for Treatment of Low Milk SupplyParticipants will receive a 20 day supply of moringa supplement for consumption per the manufacturer instructions |
| Shatavari Supplement | Experimental | Dietary Supplement: Galactagogue Supplement for Treatment of Low Milk SupplyParticipants will receive a 20 day supply of shatavari supplement for consumption per the manufacturer instructions |
| Placebo | Placebo comparator | Dietary Supplement: Galactagogue Supplement for Treatment of Low Milk SupplyParticipants 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 may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Galactagogue Supplement for Treatment of Low Milk SupplyParticipants will consume a commercially available dietary supplement on the market for augmentation of breast milk production in lactating women with low milk supply | Dietary supplement | Moringa Supplement, Oat Mama Lactation Supplement, Placebo, Shatavari Supplement |
Primary outcome
Change in Breast Milk Supply
Time frame: 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 breast milk supply will be evaluated using 24-hour breast milk expression volume
Change in Serum Prolactin
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No. There will be no sharing of individual participant data to researchers outside of the experimental team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hope K Lima, PhD principal investigator
Winthrop University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Galactagogue Supplement for Treatment of Low Milk Supply in people with Breast Milk Expression, run by Winthrop University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hope K Lima, PhD (803-323-4540, limah@winthrop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Breast Milk Supply (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.