Fat Globules in Breast MilkNCT01034722
Fat Globules in Breast Milk
An observational study of Fat Globules in Breast Milk, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The aims of this study is: 1. To investigate the diet influence on size and composition of fat globules in breast milk under controlled diet. 2. To study the changes in globules distribution along one session of lactation and during the day. Study design: Subjects: This will be a open label study. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fat Globules in Breast Milk
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2009to Dec 2011
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Study population will include 45 volunteer mothers, that will divide to 3 groups: 15 vegetarians, 15 western diet and 15 Bedouins. Each participant will be nursing a 2-5 months baby.
Who may be able to join
- Healthy Volunteers nursing only babies aged 2-5 months.
- Age: 20-45 years old.
- Written informed consent.
Who cannot join
- Nursing babies more than 5 months or less than 2 months.
- Infants who consume breast milk replacement formulas on top of breast milk.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Tel Aviv Medical Center
Tel Aviv
Nachum Vaisman, Prof', 00-972-3-6974807, vaisman@tasmc.health.gov.il
About this study
The aims of this study is:
- To investigate the diet influence on size and composition of fat globules in breast milk under controlled diet.
- To study the changes in globules distribution along one session of lactation and during the day.
Read more
Study design:
Subjects:
This will be a open label study. Each subject will serve as his own control. Study population will include 45 volunteer mothers, that will divide to 3 groups: 15 vegetarians, 15 western diet and 15 Bedouins.
Each participant will be nursing a 2-5 months baby. Each participant will sign an informed consent. Each participant will be ask to collect 2 milk samples twice a day i.e.- once on the first nursing in the morning (in the beginning and at the end of the nursing session), and once in the evening on last nursing again, (in the beginning and at the end). Each sample will contain 5 ml of milk.
Participants will be asked to repeat the procedure one month later.
- Conditions
- Fat Globules in Breast Milk
- Keywords
- Breast Milk, Fat Globules
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 |
|---|---|---|
| Western Diet | Volunteer mothers with western diet. | |
| Vegetarians | volunteer mothers with vegetarians diet | |
| Bedouins | Volunteer mothers who are Bedouins |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the diet influence on size and composition of fat globules in breast milk under controlled diet.
To study the changes in globules distribution along one session of lactation and during the day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fat Globules in Breast MilkStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Ecologic or community
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034722
- Sponsor's protocol ID
- TASMC-09-NV-593-CTIL
- Status last verified
- Nov 2009
- First submitted
- 16 Dec 2009
- Last updated
- 17 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fat Globules in Breast Milk
- ClinicalTrials.gov ID
- NCT01034722
- Acronym / sponsor ID
- TASMC-09-NV-593-CTIL
- Conditions
- Fat Globules in Breast Milk
- Keywords
- Breast Milk, Fat Globules
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 17 Dec 2009 (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.
The aims of this study is:
- To investigate the diet influence on size and composition of fat globules in breast milk under controlled diet.
- To study the changes in globules distribution along one session of lactation and during the day.
Study design:
Subjects:
This will be a open label study. Each subject will serve as his own control. Study population will include 45 volunteer mothers, that will divide to 3 groups: 15 vegetarians, 15 western diet and 15 Bedouins.
Each participant will be nursing a 2-5 months baby. Each participant will sign an informed consent. Each participant will be ask to collect 2 milk samples twice a day i.e.- once on the first nursing in the morning (in the beginning and at the end of the nursing session), and once in the evening on last nursing again, (in the beginning and at the end). Each sample will contain 5 ml of milk.
Participants will be asked to repeat the procedure one month later.
Study design
- Observational model
- Ecologic or community
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Western Diet | – | –Volunteer mothers with western diet. |
| Vegetarians | – | –volunteer mothers with vegetarians diet |
| Bedouins | – | –Volunteer mothers who are Bedouins |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Study population will include 45 volunteer mothers, that will divide to 3 groups: 15 vegetarians, 15 western diet and 15 Bedouins. Each participant will be nursing a 2-5 months baby.
Key inclusion criteria (3 listed)
- Healthy Volunteers nursing only babies aged 2-5 months.
- Age: 20-45 years old.
- Written informed consent.
Key exclusion criteria (2 listed)
- Nursing babies more than 5 months or less than 2 months.
- Infants who consume breast milk replacement formulas on top of breast milk.
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
To investigate the diet influence on size and composition of fat globules in breast milk under controlled diet.
To study the changes in globules distribution along one session of lactation and during the day.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2009.
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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 Fat Globules in Breast Milk, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 3 inclusion and 2 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 17 Dec 2009. 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 Israel. 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 Nachum Vaisman, Prof' (009-972-3-6974807, VAisman@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the diet influence on size and composition of fat globules in breast milk under controlled diet.. The study lists 2 primary outcomes in all. 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 17 Dec 2009.