is Dietary Manipulation of Human Milk Total Fat and Calor... | NCT00408980

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

NCT00408980

Sponsor

Shaare Zedek Medical Center

Status

Unknown status

Last Update Posted

Dec 8, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Breastfeeding

Interventions

Fat and calorie controlled diet

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 7, 2006

First Submission Date that Met QC Criteria

Dec 7, 2006

First Posted Date

Dec 8, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2006

Last Update Posted Date

Dec 8, 2006Estimated

Description Module

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.

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Fat and calorie controlled diet	Behavioral

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

breast feeding women
healthy
on no medications

Exclusion Criteria:

women on medications

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

46 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Weinstadt Morya, MD	Shaare Zedek Medical Center, Jerusalem	Principal Investigator

Locations

Not provided

ID	Term
D001942	Breast Feeding

ID	Term
D005247	Feeding Behavior
D001519	Behavior

Intervention Browse Module

MeSH Terms

ID	Term
D018955	CD36 Antigens
D031204	Caloric Restriction

Ancestor Terms

ID	Term
D010980	Platelet Membrane Glycoproteins
D008562	Membrane Glycoproteins
D006023	Glycoproteins
D006001	Glycoconjugates

Browse Leaves

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Browse Branches

Not provided