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CompletedNCT03746886Updated May 7, 2026

Lipids and Other Bioactive Compounds of Human Breast Milk

An observational study in Breast Milk Collection, sponsored by University of Turku. Completed at 1 site in Finland. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-05-07.

Sponsored by University of Turku · Observational

Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
7
Ages
18 Years to 45 Years
Sex
Female
01

Study 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 the breast milk, and ensure the optimal development of also the formula-fed babies.

02

Conditions studied

  • Breast Milk Collection

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Keywords

  • breast milk
  • lipids
  • bioactive compounds
  • infant formula
03

In context

Breast Milk Expression

88 studies on the registry are indexed under Breast Milk Expression; 20 are open to participants now.

This study's enrollment of 7 is below the median of 71 across 36 observational studies indexed under Breast Milk Expression.

Browse Breast Milk Expression studies →

Lead sponsor

University of Turku is the lead sponsor of 122 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

18-45 years old women who breast-feed their 0-6 months old child

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • breast-fed child was born full-time and is healthy.
  • age of the breast-fed child is 0-6 months

Exclusion criteria

Exclusion Criteria:

  • breast-fed child was born prematurely (gestation week \<37)
05

Study design

Observational model
Case-only
Time perspective
Other
Enrollment
7 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Breast-feeding women

    A single breast-milk sample will be collected from 20 women who breast-feed their child (0-6 months old).

    Other: Breast-milk

Interventions

  • OtherBreast-milk

    A single breast-milk sample will be collected from 20 women. Milk samples will be pooled for analysis.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 11/2018-12/2019

  2. 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.

    Time frame: 11/2018-12/2019

  3. 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.

    Time frame: 11/2018-12/2019

07

Study locations

1 site
  • Department of Biochemistry, University of Turku
    Turku, 20014, Finland
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2018 to primary completion in May 2022, 42 months.

Of 25 observational studies under Breast Milk Expression, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 44. This study's 42 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 7, 2018
First posted
Nov 20, 2018
StartActual
Nov 1, 2018
Primary completionActual
May 24, 2022
CompletionActual
May 24, 2022
Last update
May 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03746886
Responsible party
Kaisa Linderborg (Associate Professor, University of Turku) — Principal investigator
First posted
Nov 20, 2018
Start date
Nov 1, 2018
Primary completion
May 24, 2022
Completion
May 24, 2022
Last update
May 7, 2026

Study contacts

Kaisa M Linderborg, PhD
principal investigator · University of Turku

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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