is Dietary Manipulation of Human Milk Total Fat and Caloric Content Feasible?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by Shaare Zedek Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00408980
First received: December 7, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  Purpose

The aim of this study is to verify whether dietary manipulations in lactating women allow increasing the fat and caloric content of human milk.


Condition Intervention
Breastfeeding
Behavioral: Fat and calorie controlled diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Screening
Official Title: is Dietary Manipulation of Human Milk Total Fat and Caloric Content Feasible?

Further study details as provided by Shaare Zedek Medical Center:

Estimated Enrollment: 20
Study Start Date: January 2007
Detailed Description:

The aim of this study is to verify whether dietary manipulations in lactating women allow increasing the fat and caloric content of human milk. specifically, we will test the following hypotheses:1) at constant caloric intake, 2 high fat (40% fat, 45% CHO) diets ( margarine e nriched versus butter enriched) lead to higher fat and caloric content of human milk than the low fat diet (5% fat, 80% CHO); and 2) All 3 groups will have strikingly different milk fatty acid profiles (mirroring the dietary fatty acid profile).

  Eligibility

Ages Eligible for Study:   18 Years to 46 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • breast feeding women
  • healthy
  • on no medications

Exclusion Criteria:

  • women on medications
  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: NCT00408980

Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Weinstadt Morya, MD Shaare Zedek Medical Center, Jerusalem
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00408980     History of Changes
Other Study ID Numbers: breastmilk.ctil
Study First Received: December 7, 2006
Last Updated: December 7, 2006
Health Authority: Israel: Pharmaceutical Board

Keywords provided by Shaare Zedek Medical Center:
diet
breast milk fat

ClinicalTrials.gov processed this record on October 21, 2014