Lipids and Other Bioactive Compounds of Human Breast Milk

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Milk Collection
• Intervention / Treatment: Other: Breast-milk

• Study Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

• Study Contact: Name: Kaisa M Linderborg, PhD; Phone Number: +358 2 333 6872; Email: kaisa.linderborg@utu.fi

Study Locations

• Finland
  • Turku, Finland, 20014
    • Recruiting
    • Department of Biochemistry, University of Turku
    • Contact: Kaisa M Linderborg, PhD; Phone Number: +358 2 333 6872; Email: kaisa.linderborg@utu.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; A single breast-milk sample will be collected from 20 women. Milk samples will be pooled for analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Turku
• Investigators: Principal Investigator: Kaisa M Linderborg, PhD, University of Turku

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: November 7, 2018
• First Submitted That Met QC Criteria: November 15, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: lipids; breast milk; infant formula; bioactive compounds
• Other Study ID Numbers: Korvike

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No