Lipids and Other Bioactive Compounds of Human Breast Milk
1 other identifier
observational
7
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2018
CompletedFirst Submitted
Initial submission to the registry
November 7, 2018
CompletedFirst Posted
Study publicly available on registry
November 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 24, 2022
CompletedMay 7, 2026
May 1, 2021
3.6 years
November 7, 2018
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
11/2018-12/2019
Study Arms (1)
Breast-feeding women
A single breast-milk sample will be collected from 20 women who breast-feed their child (0-6 months old).
Interventions
A single breast-milk sample will be collected from 20 women. Milk samples will be pooled for analysis.
Eligibility Criteria
18-45 years old women who breast-feed their 0-6 months old child
You may qualify if:
- breast-fed child was born full-time and is healthy.
- age of the breast-fed child is 0-6 months
You may not qualify if:
- breast-fed child was born prematurely (gestation week \<37)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Biochemistry, University of Turku
Turku, 20014, Finland
Biospecimen
Human breast-milk samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kaisa M Linderborg, PhD
University of Turku
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 7, 2018
First Posted
November 20, 2018
Study Start
November 1, 2018
Primary Completion
May 24, 2022
Study Completion
May 24, 2022
Last Updated
May 7, 2026
Record last verified: 2021-05