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Completed

NCT Number: NCT05516940

A Study of the Impact of Different Delivery Modes on Specific Macronutrient Components in Human Milk

The aim of the study is to evaluate the impact of different delivery modes on specific macronutrient components in human milk.

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Key information

Conditions

Healthy

Sex eligibility

Female

Study type

Observational

Primary location

Chinese Center for Disease Control and Prevention, National Institute for Nutrition and Health

Beijing, China

About this study

The main objective of the study is to explore the differences in human milk composition from mothers delivering by Caesarean-section and normal vaginal deliveries. To further associate the differences found in human milk composition to infant outcomes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Human milk to be selected from the mothers who have delivered at full term (>37 weeks of gestation).
  • 125 subjects will be selected who have delivered infants by Caesarean-section.
  • 125 subjects will be selected who have delivered infants by vaginal/normal deliveries.
  • Subjects will be selected based on sample availability.
  • Based on sample availability to balance by stage of lactation, geographical locations within China.
  • Subjects of Han ethnicity.
  • The collection of existing biological material and/or health-related personal data have been consented in the frame of the approved original study scope. We will propose to the participants to consent to this specific research.

Exclusion criteria

  • Incomplete information either for the subject or the sample collected.

Treatment and study plan

Primary outcomes

  1. Differences in HMO from mothers' milk who delivered by Caesarean-section and normal vaginal deliveries.

    Time frame: baseline (no primary mothers' milk collection, but from existing human milk samples)

    HMO will be analyzed by HPLC-FLD

Secondary outcomes

  1. Differences in human milk fat from mothers who delivered by Caesarean-section and normal vaginal deliveries.

    Time frame: baseline (no primary collection, but from existing human milk samples)

    Fatty acid will be analyzed by GC-FID

  2. Differences in human milk proteins from mothers who delivered by Caesarean-section and normal vaginal deliveries.

    Time frame: baseline (no primary collection, but from existing human milk samples)

    Proteins will be analyzed by Ultra-high phase liquid chromatography

  3. Differences in human milk gangliosides from mothers who delivered by Caesarean-section and normal vaginal deliveries.

    Time frame: baseline (no primary collection, but from existing human milk samples)

    gangliosides will be analyzed by GC-MS

  4. Association of the differences in human milk composition with subject-reported outcomes

    Time frame: baseline (no primary collection, but from the existing questionnaires)

    The subject-reported outcomes were existing information in the questionnaires

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Collaborators

  • Nationtial Institute of Nutrition and Health, China CDC
  • SAS Institute
  • Veeva Systems

Registry information

Acronym: ZoomMING

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 26, 2022
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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