MedPath

Fat Globules in Breast Milk

Conditions
Fat Globules in Breast Milk
Registration Number
NCT01034722
Lead Sponsor
Tel-Aviv Sourasky Medical Center
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
45
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

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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.
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Tel Aviv Medical Center

🇮🇱

Tel Aviv, Israel

© Copyright 2025. All Rights Reserved by MedPath