Breast Milk CollectionNCT03746886
Lipids and Other Bioactive Compounds of Human Breast Milk
An observational study of Breast Milk Collection, run by University of Turku at 1 site in Finland.
Trial summary
The biochemical differences in the composition of breast milk and formula have not been profoundly established in all compound groups. Increased understanding of breast milk composition, the normal variation of various bioactive compounds and their levels is required to be able to develop formulas better corresponding… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Breast Milk Collection
- What is being tested?
- Breast-milk
- How many people
- 7 participants
- Where
- 1 siteFinland
- Study dates
- 1 Nov 2018to 24 May 2022
- Phase
- Observational
- 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 45 years
- Women only
- Adult
Study population: 18-45 years old women who breast-feed their 0-6 months old child
Who may be able to join
- breast-fed child was born full-time and is healthy.
- age of the breast-fed child is 0-6 months
Who cannot join
- breast-fed child was born prematurely (gestation week <37)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lipids and Other Bioactive Compounds of Human Breast Milk and Infant Formulas.
The biochemical differences in the composition of breast milk and formula have not been profoundly established in all compound groups. Increased understanding of breast milk composition, the normal variation of various bioactive compounds and their levels is required to be able to develop formulas better corresponding the breast milk, and ensure the optimal development of also the formula-fed babies.
- Conditions
- Breast Milk Collection
- Being tested
- Breast-milk
- Keywords
- breast milk, lipids, bioactive compounds, infant formula
- 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.
Breast-milkOther
A single breast-milk sample will be collected from 20 women. Milk samples will be pooled for analysis.
| Study group | Role | What they receive |
|---|---|---|
| Breast-feeding women | A single breast-milk sample will be collected from 20 women who breast-feed their child (0-6 months old). Receives: Other: Breast-milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative proportions (%) of regioisomers within selected molecular species (acyl carbon number:number of double bonds 50:1 and 52:2) in triacylglycerols.
Isolation of lipids from the milk with solvent extraction. Isolation of triacylglycerols with solid phase extraction. Negative ionization of the triacylglycerols with ammonia. Selection of the molecular weight species in the first quadruple of the MS/MS. Fragmentation of the selected ions with argon. Separation of the fragment ions in the second quadrupole of the MS/MS. Calculation of the relative proportions of regioisomers with a computer software.
Measured: 11/2018-12/2019
Relative proportions (%) of fatty acids in triacylglycerols of human milk.
Isolation of lipids from the milk with solvent extraction. Isolation of triacylglycerols with solid phase extraction. Quantitation with gas chromatograph coupled with flame ionization detector in relation to external standards.
Measured: 11/2018-12/2019
Quantity (mg/ml) of lipid soluble compounds in triacylglycerols of human milk.
Isolation of lipids from the milk with solvent extraction. Gravimetric analysis of the lipids.
Measured: 11/2018-12/2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start1 Nov 2018
- Primary completion24 May 2022
- Study completion24 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Milk CollectionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaisa Linderborg, University of Turku
- Investigators
- Kaisa M Linderborg, PhD, Principal investigator, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746886
- Sponsor's protocol ID
- Korvike
- Status last verified
- May 2021
- First submitted
- 7 Nov 2018
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipids and Other Bioactive Compounds of Human Breast Milk and Infant Formulas.
- ClinicalTrials.gov ID
- NCT03746886
- Acronym / sponsor ID
- Korvike
- Conditions
- Breast Milk Collection
- Keywords
- breast milk, lipids, bioactive compounds, infant formula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 24 May 2022 (actual)
- First posted
- 20 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.
The biochemical differences in the composition of breast milk and formula have not been profoundly established in all compound groups. Increased understanding of breast milk composition, the normal variation of various bioactive compounds and their levels is required to be able to develop formulas better corresponding the breast milk, and ensure the optimal development of also the formula-fed babies.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast-feeding women | – | Other: Breast-milkA single breast-milk sample will be collected from 20 women who breast-feed their child (0-6 months old). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- 18-45 years old women who breast-feed their 0-6 months old child
Key inclusion criteria (2 listed)
- breast-fed child was born full-time and is healthy.
- age of the breast-fed child is 0-6 months
Key exclusion criteria (1 listed)
- breast-fed child was born prematurely (gestation week <37)
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 |
|---|---|---|
| Breast-milkA single breast-milk sample will be collected from 20 women. Milk samples will be pooled for analysis. | Other | Breast-feeding women |
Primary outcome
Relative proportions (%) of regioisomers within selected molecular species (acyl carbon number:number of double bonds 50:1 and 52:2) in triacylglycerols.
Time frame: 11/2018-12/2019
Isolation of lipids from the milk with solvent extraction. Isolation of triacylglycerols with solid phase extraction. Negative ionization of the triacylglycerols with ammonia. Selection of the molecular weight species in the first quadruple of the MS/MS. Fragmentation of the selected ions with argon. Separation of the fragment ions in the second quadrupole of the MS/MS. Calculation of the relative proportions of regioisomers with a computer software.
Relative proportions (%) of fatty acids in triacylglycerols of human milk.
Time frame: 11/2018-12/2019
Isolation of lipids from the milk with solvent extraction. Isolation of triacylglycerols with solid phase extraction. Quantitation with gas chromatograph coupled with flame ionization detector in relation to external standards.
Quantity (mg/ml) of lipid soluble compounds in triacylglycerols of human milk.
Time frame: 11/2018-12/2019
Isolation of lipids from the milk with solvent extraction. Gravimetric analysis of the lipids.
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 7 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Kaisa M Linderborg, PhD principal investigator
University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Milk Collection, run by University of Turku at 1 site in Finland.
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 2 inclusion and 1 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 7 May 2026. 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 Finland. 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?
Relative proportions (%) of regioisomers within selected molecular species (acyl carbon number:number of double bonds 50:1 and 52:2) in triacylglycerols. (time frame: 11/2018-12/2019). The study lists 3 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 7 May 2026.