Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

December 7, 2006
December 7, 2006
January 2007
Not Provided
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
is Dietary Manipulation of Human Milk Total Fat and Caloric Content Feasible?
is Dietary Manipulation of Human Milk Total Fat and Caloric Content Feasible?

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

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).

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Screening
Breastfeeding
Behavioral: Fat and calorie controlled diet
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
Not Provided
Not Provided

Inclusion Criteria:

  • breast feeding women
  • healthy
  • on no medications

Exclusion Criteria:

  • women on medications
Female
18 Years to 46 Years
Yes
Not Provided
 
NCT00408980
breastmilk.ctil
Not Provided
Not Provided
Shaare Zedek Medical Center
Not Provided
Principal Investigator: Weinstadt Morya, MD Shaare Zedek Medical Center, Jerusalem
Shaare Zedek Medical Center
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP