Fat Globules in Breast Milk

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Fat Globules in Breast Milk

Study type: Observational

Funder types: Other

Identifiers

NCT01034722

TASMC-09-NV-593-CTIL

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

45 participants in 3 patient groups

Western Diet

Description:

Volunteer mothers with western diet.

Vegetarians

Description:

volunteer mothers with vegetarians diet

Bedouins

Description:

Volunteer mothers who are Bedouins