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NCT00408980 Clinical Trial

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

Breastfeeding Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00408980
Other study ID # breastmilk.ctil
Secondary ID
Status Not yet recruiting
Phase N/A
First received December 7, 2006
Last updated December 7, 2006
Start date January 2007

Study information
Verified date November 2006
Source Shaare Zedek Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Pharmaceutical Board
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 46 Years
Eligibility Inclusion Criteria:

- breast feeding women

- healthy

- on no medications

Exclusion Criteria:

- women on medications

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Behavioral:
• Fat and calorie controlled diet

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Shaare Zedek Medical Center
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