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

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ClinicalTrials.gov Identifier: NCT00408980
Recruitment Status : Unknown
Verified November 2006 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 8, 2006
Last Update Posted : December 8, 2006
Sponsor:
Information provided by:
Shaare Zedek Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Breastfeeding Behavioral: Fat and calorie controlled diet Not Applicable

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).

Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Screening
Official Title: is Dietary Manipulation of Human Milk Total Fat and Caloric Content Feasible?
Study Start Date : January 2007




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Ages Eligible for Study:   18 Years to 46 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • breast feeding women
  • healthy
  • on no medications

Exclusion Criteria:

  • women on medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00408980


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

ClinicalTrials.gov Identifier: NCT00408980     History of Changes
Other Study ID Numbers: breastmilk.ctil
First Posted: December 8, 2006    Key Record Dates
Last Update Posted: December 8, 2006
Last Verified: November 2006

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