HealthyZoomMINGNCT05516940
A Study of the Impact of Different Delivery Modes on Specific Macronutrient Components in Human Milk
An observational study of Healthy, run by Société des Produits Nestlé (SPN) at 1 site in China.
Trial summary
The aim of the study is to evaluate the impact of different delivery modes on specific macronutrient components in human milk. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2022to 30 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population of interest is mothers that have delivered at full term (>37 weeks of gestation) who have already provided human milk samples collected within China CDC's cross sectional multi-centric human milk study conducted in China.
Who may be able to join
- 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.
Who cannot join
- 1) Incomplete information either for the subject or the sample collected.
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese Center for Disease Control and Prevention, National Institute for Nutrition and Health
Beijing
About this study
The aim of the study is to evaluate the impact of different delivery modes on specific macronutrient components in human milk.
Read the detailed description
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.
- Conditions
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| Caesarean-section | 125 subjects will be selected who have delivered infants by Caesarean-section. | |
| Normal delivery | 125 subjects will be selected who have delivered infants by vaginal/normal deliveries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in HMO from mothers' milk who delivered by Caesarean-section and normal vaginal deliveries.
HMO will be analyzed by HPLC-FLD
Measured: baseline (no primary mothers' milk collection, but from existing human milk samples)
Secondary outcomes (4)
Differences in human milk fat from mothers who delivered by Caesarean-section and normal vaginal deliveries.
Fatty acid will be analyzed by GC-FID
Measured: baseline (no primary collection, but from existing human milk samples)
Differences in human milk proteins from mothers who delivered by Caesarean-section and normal vaginal deliveries.
Proteins will be analyzed by Ultra-high phase liquid chromatography
Measured: baseline (no primary collection, but from existing human milk samples)
Differences in human milk gangliosides from mothers who delivered by Caesarean-section and normal vaginal deliveries.
gangliosides will be analyzed by GC-MS
Measured: baseline (no primary collection, but from existing human milk samples)
Association of the differences in human milk composition with subject-reported outcomes
The subject-reported outcomes were existing information in the questionnaires
Measured: baseline (no primary collection, but from the existing questionnaires)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start6 May 2022
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nationtial Institute of Nutrition and Health, China CDC, SAS Institute, Veeva Systems
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516940
- Sponsor's protocol ID
- 21.08.NR
- Acronym
- ZoomMING
- Status last verified
- Nov 2025
- First submitted
- 25 Jul 2022
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Impact of Different Delivery Modes on Specific Macronutrient Components in Human Milk
- ClinicalTrials.gov ID
- NCT05516940
- Acronym / sponsor ID
- ZoomMING / 21.08.NR
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- Nationtial Institute of Nutrition and Health, China CDC, SAS Institute, Veeva Systems
- Study start
- 6 May 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate the impact of different delivery modes on specific macronutrient components in human milk.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caesarean-section | – | –125 subjects will be selected who have delivered infants by Caesarean-section. |
| Normal delivery | – | –125 subjects will be selected who have delivered infants by vaginal/normal deliveries |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population of interest is mothers that have delivered at full term (>37 weeks of gestation) who have already provided human milk samples collected within China CDC's cross sectional multi-centric human milk study conducted in China.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- 1) Incomplete information either for the subject or the sample collected.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other | Caesarean-section, Normal delivery |
Primary outcome
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
4 secondary outcomes
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)
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)
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)
Association of the differences in human milk composition with subject-reported outcomes
Time frame: baseline (no primary collection, but from the existing questionnaires)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Société des Produits Nestlé (SPN) at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.