BreastfeedingNCT04805008
Lactation Cookie Study
A study testing Lactation cookies in people with Breastfeeding, run by Indiana University at 1 site in United States.
Trial summary
Lactation cookies contain ingredients thought to increase breast milk production. Although these cookies are widely purchased and consumed with the intention to increase breast milk supply, no scientific investigation has explored the effects of lactation cookies on human breast milk production. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Lactation cookies
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2021to 17 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Living in the contiguous continental 48 states in the US
- Mother of a healthy child born at 37 weeks or later from an uncomplicated birth
- Mother must be 18 years old or older
- Infant aged 2-months at enrollment
- Must intend to exclusively breastfeed infant for at least 3 months after birth
- Must have a working weight scale at home
Show all 9Show fewer
- No formula use in 2 weeks prior to enrollment or plan to use during the study (1 month)
- Must not have any food or cookie ingredient allergies, dislikes, or contraindications to consume cookies
- Intending to bring the child to CDC recommended well-child visits
Who cannot join
- Previous or current diagnosis of thyroid disease, epilepsy, psychosis, bipolar disorder
- Receiving treatment for depression or anxiety, or medications that may interfere with milk production (e.g. metoclopramide, chlorpromazine, domperidone, medroxyprogesterone, thyroid hormone).
- Substance use disorder
- Formula feeding or consuming other lactation boosting products during the study
- Having eaten lactation cookies in previous two weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University - Bloomington
Bloomington, Indiana, 47405
About this study
Official title: The Lactation Cookie Study
Lactation cookies contain ingredients thought to increase breast milk production. Although these cookies are widely purchased and consumed with the intention to increase breast milk supply, no scientific investigation has explored the effects of lactation cookies on human breast milk production.
This study will evaluate the effects of a lactation cookie in breast milk production, relative to cookies without ingredients thought to increase breast milk production in exclusively breastfeeding mothers of healthy, term babies.
Read the detailed description
Caring for an infant is demanding, and breastfeeding can become a stressful experience, particularly if mothers are concerned about their breast milk supply or whether their milk is nutritious enough to meet their infant's nutritional needs.
In the US, research suggests that about 60% of women perceive their breast milk as insufficient to meet their infant's nutritional needs. As a consequence, about one-fourth of women that perceive insufficient milk production wean their infants prematurely.
Lactation cookies contain ingredients thought to increase breast milk production and are widely consumed for this purpose. However, there is no research that has explored the effects of lactation cookies on breast milk supply. To answer this, the investigators plan a randomized controlled trial involving 176 exclusively breastfeeding mothers of 2-month-old infants. Participants will be randomized into "lactation cookies" or "control cookies" (cookies without ingredients thought to increase breast milk production" and will be asked to eat a bag (2 OZ) of cookies per day for 1 month.
- Conditions
- Breastfeeding
- Being tested
- Lactation cookies, Control cookies
- Keywords
- Breastfeeding, lactation cookies, breast milk production
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactation cookiesOther
1 serving of 2 OZ of cookies per day for 30 consecutive days. These cookies will contain ingredients thought to increase breast milk production.
Control cookiesOther
1 serving of 2 OZ of cookies per day for 30 consecutive days.
The cookies will not contain ingredients thought to increase breast milk production.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Lactation cookies Receives: Other: Lactation cookies |
| Control | Placebo comparator | Control cookies Receives: Other: Control cookies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in breast milk production from baseline to 1-month post intervention
Assessed using the Roznowski 3-hour breast milk expression protocol (milk production hourly rate)
Measured: 1 month
Secondary outcomes (1)
Changes in perceived milk supply scores from baseline to 1-month post intervention
Assessed using the McCarter-Spaulding Perceived Insufficient Milk Questionnaire
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start18 Mar 2021
- Primary completion17 Dec 2021
- Study completion17 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida
- Responsible party
- Principal investigator, Ana M. Palacios, Indiana University
- Investigators
- Ana Palacios, MD, PhD, Principal investigator, Indiana University, BloomingtonDavid Allison, PhD, Principal investigator, Indiana University, Bloomington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805008
- Sponsor's protocol ID
- 10036
- Status last verified
- Jan 2022
- First submitted
- 16 Mar 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data related to the analysis and results of the primary and secondary outcomes listed herein will be available after deidentification.
Publications
Palacios AM, Lemas DJ, Young BE, Parker E, Dickinson S, Marshall N, Sullivan KL, Wilt H, Cardel MI, Allison DB. Associations among Human Milk Polyunsaturated Fatty Acids and Infant Sleep Patterns: A Cross-Sectional Study. J Nutr. 2025 Oct;155(10):3426-3433. doi: 10.1016/j.tjnut.2025.07.021. Epub 2025 Aug 5.
PubMed 40754212Palacios AM, Cardel MI, Parker E, Dickinson S, Houin VR, Young B, Allison DB. Effectiveness of lactation cookies on human milk production rates: a randomized controlled trial. Am J Clin Nutr. 2023 May;117(5):1035-1042. doi: 10.1016/j.ajcnut.2023.03.010. Epub 2023 Mar 14.
PubMed 36921902
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Lactation Cookie Study
- ClinicalTrials.gov ID
- NCT04805008
- Acronym / sponsor ID
- 10036
- Conditions
- Breastfeeding
- Keywords
- Breastfeeding, lactation cookies, breast milk production
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- University of Florida
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 18 Mar 2021 (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.
Lactation cookies contain ingredients thought to increase breast milk production. Although these cookies are widely purchased and consumed with the intention to increase breast milk supply, no scientific investigation has explored the effects of lactation cookies on human breast milk production.
This study will evaluate the effects of a lactation cookie in breast milk production, relative to cookies without ingredients thought to increase breast milk production in exclusively breastfeeding mothers of healthy, term babies.
Detailed description
Caring for an infant is demanding, and breastfeeding can become a stressful experience, particularly if mothers are concerned about their breast milk supply or whether their milk is nutritious enough to meet their infant's nutritional needs.
In the US, research suggests that about 60% of women perceive their breast milk as insufficient to meet their infant's nutritional needs. As a consequence, about one-fourth of women that perceive insufficient milk production wean their infants prematurely.
Lactation cookies contain ingredients thought to increase breast milk production and are widely consumed for this purpose. However, there is no research that has explored the effects of lactation cookies on breast milk supply. To answer this, the investigators plan a randomized controlled trial involving 176 exclusively breastfeeding mothers of 2-month-old infants. Participants will be randomized into "lactation cookies" or "control cookies" (cookies without ingredients thought to increase breast milk production" and will be asked to eat a bag (2 OZ) of cookies per day for 1 month.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Lactation cookiesLactation cookies |
| Control | Placebo comparator | Other: Control cookiesControl cookies |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Living in the contiguous continental 48 states in the US
- Mother of a healthy child born at 37 weeks or later from an uncomplicated birth
- Mother must be 18 years old or older
- Infant aged 2-months at enrollment
- Must intend to exclusively breastfeed infant for at least 3 months after birth
Key exclusion criteria (5 listed)
- Previous or current diagnosis of thyroid disease, epilepsy, psychosis, bipolar disorder
- Receiving treatment for depression or anxiety, or medications that may interfere with milk production (e.g. metoclopramide, chlorpromazine, domperidone, medroxyprogesterone, thyroid hormone).
- Substance use disorder
- Formula feeding or consuming other lactation boosting products during the study
- Having eaten lactation cookies in previous two weeks
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 |
|---|---|---|
| Lactation cookies1 serving of 2 OZ of cookies per day for 30 consecutive days. These cookies will contain ingredients thought to increase breast milk production. | Other | Intervention |
| Control cookies1 serving of 2 OZ of cookies per day for 30 consecutive days. The cookies will not contain ingredients thought to increase breast milk production. | Other | Control |
Primary outcome
Changes in breast milk production from baseline to 1-month post intervention
Time frame: 1 month
Assessed using the Roznowski 3-hour breast milk expression protocol (milk production hourly rate)
1 secondary outcome
Changes in perceived milk supply scores from baseline to 1-month post intervention
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Derived from this study: PubMed 40754212Palacios AM, Lemas DJ, Young BE, Parker E, Dickinson S, Marshall N, Sullivan KL, Wilt H, Cardel MI, Allison DB. Associations among Human Milk Polyunsaturated Fatty Acids and Infant Sleep Patterns: A Cross-Sectional Study. J Nutr. 2025 Oct;155(10):3426-3433. doi: 10.1016/j.tjnut.2025.07.021. Epub 2025 Aug 5.
- Derived from this study: PubMed 36921902Palacios AM, Cardel MI, Parker E, Dickinson S, Houin VR, Young B, Allison DB. Effectiveness of lactation cookies on human milk production rates: a randomized controlled trial. Am J Clin Nutr. 2023 May;117(5):1035-1042. doi: 10.1016/j.ajcnut.2023.03.010. Epub 2023 Mar 14.
- Individual participant dataSharing planned: Yes. Individual participant data related to the analysis and results of the primary and secondary outcomes listed herein will be available after deidentification.
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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. This study is not recruiting at the moment.
Ana Palacios, MD, PhD principal investigator
Indiana University, Bloomington
David Allison, PhD principal investigator
Indiana University, Bloomington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactation cookies in people with Breastfeeding, run by Indiana 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 9 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: finished, as of the sponsor's last update on 21 Jan 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in breast milk production from baseline to 1-month post intervention (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04805008, which also lists 2 linked publications.
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 21 Jan 2022.