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Completed

NCT Number: NCT03746886

Lipids and Other Bioactive Compounds of Human Breast Milk

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.

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Key information

Conditions

Breast Milk Collection Behavior Breast Feeding Breast Milk Expression Feeding Behavior

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Biochemistry, University of Turku

Turku, 20014, Finland

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Breast-milk

Other

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

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.

    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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Registry information

Official study title

Lipids and Other Bioactive Compounds of Human Breast Milk and Infant Formulas.

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Nov 20, 2018
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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