NCT03746886

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2022

Completed
Last Updated

May 7, 2026

Status Verified

May 1, 2021

Enrollment Period

3.6 years

First QC Date

November 7, 2018

Last Update Submit

May 4, 2026

Conditions

Keywords

breast milklipidsbioactive compoundsinfant formula

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).

Other: Breast-milk

Interventions

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

Breast-feeding women

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSelf-representation
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Location

Biospecimen

Retention: SAMPLES WITH DNA

Human breast-milk samples

MeSH Terms

Conditions

Breast Milk Expression

Interventions

Milk

Condition Hierarchy (Ancestors)

Breast FeedingFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Kaisa M Linderborg, PhD

    University of Turku

    PRINCIPAL INVESTIGATOR

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

Locations