Fat Globules in Breast Milk

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01034722
First received: December 16, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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. 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.


Condition
Fat Globules in Breast Milk

Study Type: Observational
Study Design: Observational Model: Ecologic or Community

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • To investigate the diet influence on size and composition of fat globules in breast milk under controlled diet. [ Designated as safety issue: No ]
  • To study the changes in globules distribution along one session of lactation and during the day. [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: December 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Western Diet
Volunteer mothers with western diet.
Vegetarians
volunteer mothers with vegetarians diet
Bedouins
Volunteer mothers who are Bedouins

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.

Criteria

Inclusion Criteria:

  • Healthy Volunteers nursing only babies aged 2-5 months.
  • Age: 20-45 years old.
  • Written informed consent.

Exclusion Criteria:

  • Nursing babies more than 5 months or less than 2 months.
  • Infants who consume breast milk replacement formulas on top of breast milk.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01034722

Contacts
Contact: Nachum Vaisman, Prof' 009-972-3-6974807 VAisman@tasmc.health.gov.il

Locations
Israel
Tel Aviv Medical Center Not yet recruiting
Tel Aviv, Israel
Contact: Nachum Vaisman, Prof'    00-972-3-6974807    vaisman@tasmc.health.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Prof' Nachum Vaisman, Tel Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01034722     History of Changes
Other Study ID Numbers: TASMC-09-NV-593-CTIL
Study First Received: December 16, 2009
Last Updated: December 16, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
Breast Milk
Fat Globules

ClinicalTrials.gov processed this record on July 22, 2014