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

December 7, 2006 updated by: Shaare Zedek Medical Center
The aim of this study is to verify whether dietary manipulations in lactating women allow increasing the fat and caloric content of human milk.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 46 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • breast feeding women
  • healthy
  • on no medications

Exclusion Criteria:

  • women on medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaare Zedek Medical Center

Investigators

  • Principal Investigator: Weinstadt Morya, MD, Shaare Zedek Medical Center, Jerusalem

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Study Registration Dates

First Submitted

December 7, 2006

First Submitted That Met QC Criteria

December 7, 2006

First Posted (Estimate)

December 8, 2006

Study Record Updates

Last Update Posted (Estimate)

December 8, 2006

Last Update Submitted That Met QC Criteria

December 7, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • breastmilk.ctil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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