Breast Milk CollectionNCT05133466
Odour Characteristics of Human Breast Milk of Chinese Mothers
An observational study of Breast Milk Collection, run by Heilongjiang Feihe Dairy Co. Ltd. at 1 site in China.
Trial summary
It is well known that breast milk exerts many positive effects on the general health, growth and development of infants. When breastfeeding is not possible, infant formula is considered to be an effective substitute to satisfy the regular nutritional demand of infants. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Milk Collection
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2021to Sep 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 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy lactating mothers (aged 25-35 years) who breast-feed their infants (aged 15-180 days).
Who may be able to join
- Lactating mother aged 25 ~ 35 years
- Breastfeeding infants (aged 15 ~180 days) and express sufficient breast milk
- Mother is in good health and has balanced nutrition
- Mother is non smoker and non alcoholic, no smokers living in the same apartment
- Voluntarily signed the Informed Consent Form
Who cannot join
- Mother or newborn infant has major diseases
- Mother participating in any other nutritional or pharmaceutical intervention studies recently
- Other conditions that are not suitable for this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Health Science Center
Beijing, Beijing Municipality, 100191
Han Sun, M.S., +86 010-84574688, sunhan@feihe.com
About this study
It is well known that breast milk exerts many positive effects on the general health, growth and development of infants. When breastfeeding is not possible, infant formula is considered to be an effective substitute to satisfy the regular nutritional demand of infants. At present, researchers make every effort to simulate the nutritional status of breast milk but mostly neglect the important role that odour plays in guiding the baby to recognize breast milk, promoting the baby's sucking behavior and food intake. The odour changes of the breast milk are so far mainly related to storage, lactational stage and maternal diet. To understand the odour characteristics of the human breast milk from different regions in China, 90 mothers will be recruited from three Chinese cities: Beijing, Chengdu and Wuxi, representing three typical regions with very different climate characteristics and diet habits. The breast milk samples as well as infant formulas will be analyzed using the identical state of the art separation and identification techniques to identify the odorous compounds, determine their concentrations in the breast milk and infant formula as well as determine their importance in contributing to the total odour of samples. The final objective of this study will be to mimic the odour of the breast milk and to understand the difference of breast milk odour from different regions with very different climate and diet composition, as well as to identify the odour deviation of the infant formula from the breast milk. Our results will provide references for the preparation of new infant formula with both nutritional ingredents and odour characteristics simulating that of breast milk.
- Conditions
- Breast Milk Collection
- Medical subject headings
- Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Northern pattern | Mothers recruited from Beijing | |
| East coastal pattern | Mothers recruited from Wuxi | |
| South-western pattern | Mothers recruited from Chengdu |
What is being measured
The primary outcome is the main question the study is designed to answer.
Odour active compound and their concentrations
Gas chromatography-olfactometry/mass spectrometry and other state of the art equipments and protocols will be employed to identify the odour active compounds in the samples, and their concentration and importance in contributing to the odour will be determined.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start20 Sep 2021
- Primary completionSep 2022 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Milk CollectionStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133466
- Sponsor's protocol ID
- 2021-FEIHE-BTBU-001
- Status last verified
- Nov 2021
- First submitted
- 25 Oct 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang X, Zhang W, Zheng C, Huang C, Yao H, Wang Z, Huang K, Yan Y, Jiang S, Sun J, Xie Q, Zhang Y, Li X, Wang H. Multistage Metabolomic Analyses Reveal the Differential Effects of Infant Formula and Breast Milk on the Growth and Development of Human Small Intestinal Organoids. Mol Nutr Food Res. 2025 Aug;69(16):e70068. doi: 10.1002/mnfr.70068. Epub 2025 Jun 6.
PubMed 40478533Yu M, Xie Q, Song H, Wang L, Sun H, Jiang S, Zhang Y, Zheng C. Characterization of the odor compounds in human milk by DHS/GC x GC-O-MS: A feasible and efficient method. Food Res Int. 2023 Dec;174(Pt 1):113597. doi: 10.1016/j.foodres.2023.113597. Epub 2023 Oct 21.
PubMed 37986460
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Odour Characteristics of Human Breast Milk of Chinese Mothers
- ClinicalTrials.gov ID
- NCT05133466
- Acronym / sponsor ID
- 2021-FEIHE-BTBU-001
- Conditions
- Breast Milk Collection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Heilongjiang Feihe Dairy Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 24 Nov 2021 (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.
It is well known that breast milk exerts many positive effects on the general health, growth and development of infants. When breastfeeding is not possible, infant formula is considered to be an effective substitute to satisfy the regular nutritional demand of infants. At present, researchers make every effort to simulate the nutritional status of breast milk but mostly neglect the important role that odour plays in guiding the baby to recognize breast milk, promoting the baby's sucking behavior and food intake. The odour changes of the breast milk are so far mainly related to storage, lactational stage and maternal diet. To understand the odour characteristics of the human breast milk from different regions in China, 90 mothers will be recruited from three Chinese cities: Beijing, Chengdu and Wuxi, representing three typical regions with very different climate characteristics and diet habits. The breast milk samples as well as infant formulas will be analyzed using the identical state of the art separation and identification techniques to identify the odorous compounds, determine their concentrations in the breast milk and infant formula as well as determine their importance in contributing to the total odour of samples. The final objective of this study will be to mimic the odour of the breast milk and to understand the difference of breast milk odour from different regions with very different climate and diet composition, as well as to identify the odour deviation of the infant formula from the breast milk. Our results will provide references for the preparation of new infant formula with both nutritional ingredents and odour characteristics simulating that of breast milk.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Northern pattern | – | –Mothers recruited from Beijing |
| East coastal pattern | – | –Mothers recruited from Wuxi |
| South-western pattern | – | –Mothers recruited from Chengdu |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy lactating mothers (aged 25-35 years) who breast-feed their infants (aged 15-180 days).
Key inclusion criteria (5 listed)
- Lactating mother aged 25 ~ 35 years
- Breastfeeding infants (aged 15 ~180 days) and express sufficient breast milk
- Mother is in good health and has balanced nutrition
- Mother is non smoker and non alcoholic, no smokers living in the same apartment
- Voluntarily signed the Informed Consent Form
Key exclusion criteria (3 listed)
- Mother or newborn infant has major diseases
- Mother participating in any other nutritional or pharmaceutical intervention studies recently
- Other conditions that are not suitable for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Odour active compound and their concentrations
Time frame: Up to 2 years
Gas chromatography-olfactometry/mass spectrometry and other state of the art equipments and protocols will be employed to identify the odour active compounds in the samples, and their concentration and importance in contributing to the odour will be determined.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Derived from this study: PubMed 40478533Wang X, Zhang W, Zheng C, Huang C, Yao H, Wang Z, Huang K, Yan Y, Jiang S, Sun J, Xie Q, Zhang Y, Li X, Wang H. Multistage Metabolomic Analyses Reveal the Differential Effects of Infant Formula and Breast Milk on the Growth and Development of Human Small Intestinal Organoids. Mol Nutr Food Res. 2025 Aug;69(16):e70068. doi: 10.1002/mnfr.70068. Epub 2025 Jun 6.
- Derived from this study: PubMed 37986460Yu M, Xie Q, Song H, Wang L, Sun H, Jiang S, Zhang Y, Zheng C. Characterization of the odor compounds in human milk by DHS/GC x GC-O-MS: A feasible and efficient method. Food Res Int. 2023 Dec;174(Pt 1):113597. doi: 10.1016/j.foodres.2023.113597. Epub 2023 Oct 21.
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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.
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 Breast Milk Collection, run by Heilongjiang Feihe Dairy Co. Ltd. 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Han Sun, M.S. (+86 010-84574688, sunhan@feihe.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Odour active compound and their concentrations (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05133466, which also lists 2 linked publications.
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 24 Nov 2021.