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

NCT ID: NCT00408980

Last Updated: 2006-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Breastfeeding

Keywords

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diet breast milk fat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Interventions

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Fat and calorie controlled diet

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* breast feeding women
* healthy
* on no medications

Exclusion Criteria

* women on medications
Minimum Eligible Age

18 Years

Maximum Eligible Age

46 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Weinstadt Morya, MD

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center, Jerusalem

Other Identifiers

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breastmilk.ctil

Identifier Type: -

Identifier Source: org_study_id