Focus of Study is Healthy Chinese Lactating Mother 0-270 DaysMINGNCT01971671
Evaluation of the Nutrients Composition of Breast Milk of Chinese Lactating Mothers and Their Nutrition Intake
An observational study of Focus of Study is Healthy Chinese Lactating Mother 0-270 Days, run by Société des Produits Nestlé (SPN) at 1 site in China.
Trial summary
To understand breast milk composition during different lactating stages. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Focus of Study is Healthy Chinese Lactating Mother 0-270 Days
- How many people
- 560 participants
- Where
- 1 siteChina
- Study dates
- Aug 2011to Jan 2012
- 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: Healthy Chinese lactating mother 0-270 days after delivery (inclusive) will be enrolled.
Who may be able to join
- Chinese lactating mother 0-270 days after delivery (inclusive).
- Healthy with neither acute disease nor history of hereditary disease, gestational diabetes, hypertension, other concomitant diseases, and disability.
- Parents/ caregiver is willing to comply with the study procedure.
- Having received oral and written information about the aims and procedures of the study.
- Having obtained the her informed consent.
Who cannot join
- Subjects who are currently taking, or have taken in the last 4 weeks, or will take any medication.
- Subject who has history of psychopath and have no the dietary memory.
- Subjects who are suffering food allergy.
- Insufficient breast milk output according to the corresponding period after delivery.
- Alcoholic.
- Smokers.
- Subject who cannot be expected to comply with the study procedures.
- Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Health Science Center, Peking University
Beijing, Beijing Municipality, 100191
About this study
Official title: Evaluation of the Nutrients Composition of Breast Milk of Chinese Lactating Mothers and Nutrition Intake of Chinese Pregnant and Lactating Mothers, Infants and Young Children
To understand breast milk composition during different lactating stages.
- Being tested
- no intervention.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention.Other
| Study group | Role | What they receive |
|---|---|---|
| Chinese lactating mother | no intervention. Receives: Other: no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome is the macronutrient composition of breast milk in Chinese lactating mothers from 0 to 270 days after delivery.
Macronutrient composition includes calories (kcal/ml), total protein, fat and carbohydrate (lactose) content in breast milk.
Measured: 0-270 days after delivery
Secondary outcomes (4)
Other nutrient composition in breast milk of 0-270 days after delivery.
Beside macronutrient composition, all major minerals, vitamins will be analyzed. In addition, functional compounds, such as human milk oligosaccharides (HMOs), total/free amino acids, lipid profiles, and microbiota, will be analyzed as well.
Measured: 0-270 days after delivery.
Dietary pattern of lactating mothers of 0-270 days after delivery.
A one-time standardized 24-hour food recall survey, is utilized to access dietary pattern of subjects.
Measured: 0-270 days after delivery.
Nutrients intake and adequacy of lactating mothers of 0-270 days after delivery.
A one-time standardized 24-hour food recall survey, is utilized to access nutrient intakes and adequacy (by comparing existing local and international RDAs and DRIs databases).
Measured: 0-270 days after delivery
Nutrition supplements intake status of lactating mothers of 0-270 days after delivery.
A one-time food frequency questionnaire (FFQ), designed to access nutritional supplement usage, is being utilized.
Measured: 0-270 days after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startAug 2011
- Primary completionJan 2012
- Study completionJan 2012
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 Focus of Study is Healthy Chinese Lactating Mother 0-270 DaysStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971671
- Sponsor's protocol ID
- 11.14.NRC
- Acronym
- MING
- Status last verified
- Oct 2013
- First submitted
- 14 Oct 2013
- Last updated
- 29 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Xue Y, Redeuil KM, Gimenez EC, Vinyes-Pares G, Zhao A, He T, Yang X, Zheng Y, Zhang Y, Wang P, Thakkar SK. Regional, socioeconomic, and dietary factors influencing B-vitamins in human milk of urban Chinese lactating women at different lactation stages. BMC Nutr. 2017 Mar 7;3:22. doi: 10.1186/s40795-017-0139-1. eCollection 2017.
PubMed 32153804Yu K, Xue Y, Zhao W, Zhao A, Li W, Zhang Y, Wang P. Translation of nutrient recommendations into personalized optimal diets for Chinese urban lactating women by linear programming models. BMC Pregnancy Childbirth. 2018 Sep 18;18(1):379. doi: 10.1186/s12884-018-2008-6.
PubMed 30227842
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Nutrients Composition of Breast Milk of Chinese Lactating Mothers and Nutrition Intake of Chinese Pregnant and Lactating Mothers, Infants and Young Children
- ClinicalTrials.gov ID
- NCT01971671
- Acronym / sponsor ID
- MING / 11.14.NRC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 29 Oct 2013 (estimated)
- 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.
To understand breast milk composition during different lactating stages.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chinese lactating mother | – | Other: no intervention.no intervention. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy Chinese lactating mother 0-270 days after delivery (inclusive) will be enrolled.
Key inclusion criteria (5 listed)
- Chinese lactating mother 0-270 days after delivery (inclusive).
- Healthy with neither acute disease nor history of hereditary disease, gestational diabetes, hypertension, other concomitant diseases, and disability.
- Parents/ caregiver is willing to comply with the study procedure.
- Having received oral and written information about the aims and procedures of the study.
- Having obtained the her informed consent.
Key exclusion criteria (8 listed)
- Subjects who are currently taking, or have taken in the last 4 weeks, or will take any medication.
- Subject who has history of psychopath and have no the dietary memory.
- Subjects who are suffering food allergy.
- Insufficient breast milk output according to the corresponding period after delivery.
- Alcoholic.
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 |
|---|---|---|
| no intervention. | Other | Chinese lactating mother |
Primary outcome
Primary outcome is the macronutrient composition of breast milk in Chinese lactating mothers from 0 to 270 days after delivery.
Time frame: 0-270 days after delivery
Macronutrient composition includes calories (kcal/ml), total protein, fat and carbohydrate (lactose) content in breast milk.
4 secondary outcomes
Other nutrient composition in breast milk of 0-270 days after delivery.
Time frame: 0-270 days after delivery.
Dietary pattern of lactating mothers of 0-270 days after delivery.
Time frame: 0-270 days after delivery.
Nutrients intake and adequacy of lactating mothers of 0-270 days after delivery.
Time frame: 0-270 days after delivery
Nutrition supplements intake status of lactating mothers of 0-270 days after delivery.
Time frame: 0-270 days after delivery.
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 29 Oct 2013.
- Derived from this study: PubMed 32153804Xue Y, Redeuil KM, Gimenez EC, Vinyes-Pares G, Zhao A, He T, Yang X, Zheng Y, Zhang Y, Wang P, Thakkar SK. Regional, socioeconomic, and dietary factors influencing B-vitamins in human milk of urban Chinese lactating women at different lactation stages. BMC Nutr. 2017 Mar 7;3:22. doi: 10.1186/s40795-017-0139-1. eCollection 2017.
- Derived from this study: PubMed 30227842Yu K, Xue Y, Zhao W, Zhao A, Li W, Zhang Y, Wang P. Translation of nutrient recommendations into personalized optimal diets for Chinese urban lactating women by linear programming models. BMC Pregnancy Childbirth. 2018 Sep 18;18(1):379. doi: 10.1186/s12884-018-2008-6.
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 Focus of Study is Healthy Chinese Lactating Mother 0-270 Days, 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 5 inclusion and 8 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 29 Oct 2013. 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?
Primary outcome is the macronutrient composition of breast milk in Chinese lactating mothers from 0 to 270 days after delivery. (time frame: 0-270 days after delivery). 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 NCT01971671, 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 29 Oct 2013.