ClinicalTrials.Veeva

Menu

Fat Globules in Breast Milk

T

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

Trial contacts and locations

1

Loading...

Central trial contact

Nachum Vaisman, Prof'

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems