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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oat Mama Lactation Supplement | Experimental | Participants will receive a 20 day supply of oat mama lactation supplement for consumption per the manufacturer instructions |
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| Moringa Supplement | Experimental | Participants will receive a 20 day supply of moringa supplement for consumption per the manufacturer instructions |
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| Shatavari Supplement | Experimental | Participants will receive a 20 day supply of shatavari supplement for consumption per the manufacturer instructions |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galactagogue Supplement for Treatment of Low Milk Supply | Dietary 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 |
| 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 |
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Inclusion Criteria: Participants in the study must:
Exclusion Criteria: Participants will be excluded if:
Lactating women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hope K Lima, PhD | Contact | 803-323-4540 | limah@winthrop.edu |
| Name | Affiliation | Role |
|---|---|---|
| Hope K Lima, PhD | Winthrop University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winthrop University | Recruiting | Rock Hill | South Carolina | 29733 | United States |
There will be no sharing of individual participant data to researchers outside of the experimental team.
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| ID | Term |
|---|---|
| D061186 | Breast Milk Expression |
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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Participants will be randomized into one of four treatment groups: Oat Mama Lactation Supplement (O), moringa supplement (M), shatavari supplement (S), or control (C).
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Double-blind randomized controlled trial