Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
45 participants
OBSERVATIONAL
2009-12-31
2011-12-31
Brief Summary
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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. 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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ECOLOGIC_OR_COMMUNITY
Study Groups
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Western Diet
Volunteer mothers with western diet.
No interventions assigned to this group
Vegetarians
volunteer mothers with vegetarians diet
No interventions assigned to this group
Bedouins
Volunteer mothers who are Bedouins
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age: 20-45 years old.
* Written informed consent.
Exclusion Criteria
* Infants who consume breast milk replacement formulas on top of breast milk.
20 Years
45 Years
FEMALE
Yes
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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Tel Aviv Sourasky Medical Center
Locations
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Tel Aviv Medical Center
Tel Aviv, , Israel
Countries
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Central Contacts
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Facility Contacts
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Nachum Vaisman, Prof'
Role: primary
Other Identifiers
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TASMC-09-NV-593-CTIL
Identifier Type: -
Identifier Source: org_study_id