Lipids and Other Bioactive Compounds of Human Breast Milk

• Sponsor: University of Turku (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03746886
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Anticipated Duration (Months): 37.9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Milk Collection	Other: Breast-milk

Study Design

• Study Type: Observational
• Anticipated Enrollment: 15 participants
• Observational Model: Case-Only
• Time Perspective: Other
• Official Title: Lipids and Other Bioactive Compounds of Human Breast Milk and Infant Formulas.
• Actual Study Start Date: Nov 1, 2018
• Anticipated Primary Completion Date: Dec 30, 2021
• Anticipated Study Completion Date: Dec 30, 2021

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Relative proportions (%) of regioisomers within selected molecular species (acyl carbon number:number of double bonds 50:1 and 52:2) in triacylglycerols. [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. [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. [11/2018-12/2019]

   Isolation of lipids from the milk with solvent extraction. Gravimetric analysis of the lipids.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Biochemistry, University of Turku	Turku		Finland	20014

Sponsors and Collaborators

• University of Turku

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kaisa Linderborg, Associate Professor, University of Turku
• ClinicalTrials.gov Identifier: NCT03746886
• Other Study ID Numbers: Korvike
• First Posted: Nov 20, 2018
• Last Update Posted: May 6, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kaisa Linderborg, Associate Professor, University of Turku: breast milk; lipids; bioactive compounds; infant formula

Study Results

No Results Posted as of May 6, 2021