Healthy MothersNCT01805011
Study on Normal Ranges of Lipids in Breast Milk of Healthy Mothers
An observational study of Healthy Mothers, run by Société des Produits Nestlé (SPN).
Trial summary
This trial is undertaken to better understand the ranges of functional components normally found in human milk. This will strengthen the scientific knowledge on breast-milk composition as a "gold standard". Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Mothers
- What is being tested?
- minimum 4 months of breastfeeding
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to May 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy mothers
Who may be able to join
- Gestational age between 37 and not above 42 weeks
- 18 years old ≤ Mother ≤ 40 years old
- 18.5 ≤ pre-pregnancy BMI ≤ 29
- Mothers willing to breastfeed for the first 4 months
Who cannot join
- Gestational diabetes
- HTA < 140/90
- Mothers who are smokers while breast-feeding
About this study
This trial is undertaken to better understand the ranges of functional components normally found in human milk. This will strengthen the scientific knowledge on breast-milk composition as a "gold standard".
- Conditions
- Healthy Mothers
- Being tested
- minimum 4 months of breastfeeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimum 4 months of breastfeedingOther
| Study group | Role | What they receive |
|---|---|---|
| 50 healthy mothers | Not described Receives: Other: minimum 4 months of breastfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
levels of lipids
The primary objective of this trial is to determine the levels of lipids normally found in the breast-milk of healthy lactating mothers
Measured: After 1 month of Breastfeeding
Secondary outcomes (1)
profile and quantity of sugars
Secondary objectives include the measure of the profile and quantity of sugars found in human milk
Measured: After 1 month of breastfeeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startJul 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy MothersStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Le Ye Lee, Assistant Professor, Principal investigator, NUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805011
- Sponsor's protocol ID
- 11.08.INF
- Status last verified
- Sep 2024
- First submitted
- 4 Mar 2013
- Last updated
- 19 Sep 2024
- Results posted
- No
Publications
Sprenger N, Lee LY, De Castro CA, Steenhout P, Thakkar SK. Longitudinal change of selected human milk oligosaccharides and association to infants' growth, an observatory, single center, longitudinal cohort study. PLoS One. 2017 Feb 9;12(2):e0171814. doi: 10.1371/journal.pone.0171814. eCollection 2017.
PubMed 28182762
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Normal Ranges of Lipids in Breast Milk of Healthy Mothers
- ClinicalTrials.gov ID
- NCT01805011
- Acronym / sponsor ID
- 11.08.INF
- Conditions
- Healthy Mothers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 5 Mar 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.
This trial is undertaken to better understand the ranges of functional components normally found in human milk. This will strengthen the scientific knowledge on breast-milk composition as a "gold standard".
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 50 healthy mothers | – | Other: minimum 4 months of breastfeeding |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy mothers
Key inclusion criteria (4 listed)
- Gestational age between 37 and not above 42 weeks
- 18 years old ≤ Mother ≤ 40 years old
- 18.5 ≤ pre-pregnancy BMI ≤ 29
- Mothers willing to breastfeed for the first 4 months
Key exclusion criteria (3 listed)
- Gestational diabetes
- HTA < 140/90
- Mothers who are smokers while breast-feeding
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 |
|---|---|---|
| minimum 4 months of breastfeeding | Other | 50 healthy mothers |
Primary outcome
levels of lipids
Time frame: After 1 month of Breastfeeding
The primary objective of this trial is to determine the levels of lipids normally found in the breast-milk of healthy lactating mothers
1 secondary outcome
profile and quantity of sugars
Time frame: After 1 month of breastfeeding
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 19 Sep 2024.
- Derived from this study: PubMed 28182762Sprenger N, Lee LY, De Castro CA, Steenhout P, Thakkar SK. Longitudinal change of selected human milk oligosaccharides and association to infants' growth, an observatory, single center, longitudinal cohort study. PLoS One. 2017 Feb 9;12(2):e0171814. doi: 10.1371/journal.pone.0171814. eCollection 2017.
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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.
Le Ye Lee, Assistant Professor principal investigator
NUHS
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Mothers, run by Société des Produits Nestlé (SPN).
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 4 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
levels of lipids (time frame: After 1 month of Breastfeeding). 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 NCT01805011, which also lists 1 linked publication.
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 19 Sep 2024.