Lipids and Other Bioactive Compounds of Human Breast Milk

Breast Milk Collection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03746886
• Other study ID #: Korvike
• Status: Recruiting
• Start date: November 1, 2018
• Est. completion date: December 30, 2021

Study information

• Verified date: May 2021
• Source: University of Turku
• Contact: Kaisa M Linderborg, PhD
• Phone: +358 2 333 6872
• Email: kaisa.linderborg[@]utu.fi
• Is FDA regulated: No
• Study type: Observational

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Milk Collection

Intervention

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

Locations

Country	Name	City	State
Finland	Department of Biochemistry, University of Turku	Turku

Sponsors (1)

Lead Sponsor	Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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