Fat Globules in Breast Milk

Fat Globules in Breast Milk Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01034722
• Other study ID #: TASMC-09-NV-593-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: December 16, 2009
• Last updated: December 16, 2009
• Start date: December 2009
• Est. completion date: December 2011

Study information

• Verified date: November 2009
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Nachum Vaisman, Prof'
• Phone: 009-972-3-6974807
• Email: VAisman[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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.

Study Design

Observational Model: Ecologic or Community

Related Conditions & MeSH terms

• Fat Globules in Breast Milk

Locations

Country	Name	City	State
Israel	Tel Aviv Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the diet influence on size and composition of fat globules in breast milk under controlled diet.			No
Primary	To study the changes in globules distribution along one session of lactation and during the day.			No