Effect of Diet on Breast Milk CompositionNCT03744429
A Dietary Intervention to Modify Breast Milk Content in Obese Lactating Women
A study testing Mediterranean Diet in people with Effect of Diet on Breast Milk Composition, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
This study is a nutrition research study designed to look at how healthy meals can influence the content of breast milk. Moms will be provided with meals that follow a Mediterranean diet pattern for 4 weeks. The goal of the study is to see if breast milk content changes over the 4 week period. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Effect of Diet on Breast Milk Composition
- What is being tested?
- Mediterranean Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2019to 30 Sep 2024
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≤4.5 months postpartum
- BMI 30 - 50 kg/m2
- ≥ 18 years of age
- Singleton pregnancy
- Exclusive breastfeeding and plans to exclusively breastfeed for at least 6 months postpartum
- Mother has a breast pump
- Mother is willing to collect breast milk for a 24 hour period.
Who cannot join
- Pre-existing conditions (e.g. diabetes, hypertension, heart disease)
- Use of recreational drugs, tobacco, or alcohol
- Use of medications or supplements for which breastfeeding is contraindicated
- Child has internal metal which may be an NMR safety concern
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
About this study
This study is a nutrition research study designed to look at how healthy meals can influence the content of breast milk. Moms will be provided with meals that follow a Mediterranean diet pattern for 4 weeks. The goal of the study is to see if breast milk content changes over the 4 week period. The infants of the moms will also be included in the study to measure any changes in growth.
- Being tested
- Mediterranean Diet
- Keywords
- Breast Milk, Mediterranean Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean DietOther
Participants will be provided with meals that follow a Mediterranean meal plan.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Meal Plan | Experimental | This is a single arm study in which participants will receive meals that follow a Mediterranean diet plan for 4 weeks. Breast milk samples will be collected before, during, and after the intervention period. Receives: Other: Mediterranean Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in breast milk fat concentration by mid-infrared spectroscopy
The primary aim is to test whether the dietary intervention modifies the breast milk fat concentration of obese mothers.
Measured: The change in breast milk fat concentration will be assessed by mid-infrared spectroscopy by measuring the concentration before the participants begin the dietary intervention, 2 weeks into the intervention, and at the end of the 4-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start16 Apr 2019
- Primary completion13 Mar 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Diet on Breast Milk CompositionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chelsey Fiecke, PhD, Principal investigator, Arkansas Children's Nutrition Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744429
- Sponsor's protocol ID
- 228407
- Status last verified
- Oct 2024
- First submitted
- 31 Oct 2018
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dietary Intervention to Modify Breast Milk Content in Obese Lactating Women
- ClinicalTrials.gov ID
- NCT03744429
- Acronym / sponsor ID
- 228407
- Keywords
- Breast Milk, Mediterranean Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 16 Nov 2018 (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 is a nutrition research study designed to look at how healthy meals can influence the content of breast milk. Moms will be provided with meals that follow a Mediterranean diet pattern for 4 weeks. The goal of the study is to see if breast milk content changes over the 4 week period. The infants of the moms will also be included in the study to measure any changes in growth.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Meal Plan | Experimental | Other: Mediterranean DietThis is a single arm study in which participants will receive meals that follow a Mediterranean diet plan for 4 weeks. Breast milk samples will be collected before, during, and after the intervention period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≤4.5 months postpartum
- BMI 30 - 50 kg/m2
- ≥ 18 years of age
- Singleton pregnancy
- Exclusive breastfeeding and plans to exclusively breastfeed for at least 6 months postpartum
Key exclusion criteria (4 listed)
- Pre-existing conditions (e.g. diabetes, hypertension, heart disease)
- Use of recreational drugs, tobacco, or alcohol
- Use of medications or supplements for which breastfeeding is contraindicated
- Child has internal metal which may be an NMR safety concern
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 |
|---|---|---|
| Mediterranean DietParticipants will be provided with meals that follow a Mediterranean meal plan. | Other | Mediterranean Meal Plan |
Primary outcome
Change in breast milk fat concentration by mid-infrared spectroscopy
Time frame: The change in breast milk fat concentration will be assessed by mid-infrared spectroscopy by measuring the concentration before the participants begin the dietary intervention, 2 weeks into the intervention, and at the end of the 4-week intervention.
The primary aim is to test whether the dietary intervention modifies the breast milk fat concentration of obese mothers.
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 30 Sep 2025.
- Individual participant dataSharing planned: Undecided
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.
Chelsey Fiecke, PhD principal investigator
Arkansas Children's Nutrition Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet in people with Effect of Diet on Breast Milk Composition, run by Arkansas Children's Hospital Research Institute 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 7 inclusion and 4 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 30 Sep 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. 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?
Change in breast milk fat concentration by mid-infrared spectroscopy (time frame: The change in breast milk fat concentration will be assessed by mid-infrared spectroscopy by measuring the concentration before the participants begin the dietary intervention, 2 weeks into the intervention, and at the end of the 4-week intervention.). 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 30 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.