Low Fat Milk Intake and Cardio Vascular Risk (CVR) Indicators in Children

June 24, 2011 updated by: Instituto Nacional de Salud Publica, Mexico

Impact of Low Fat Milk Intake on Cardiovascular Risk Indicators in Children 6-13 Years of Age

Substituting whole milk intake for defatted milk will improve indicators of cardiovascular risk, i.e. total cholesterol, triglycerides, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL)cholesterol, apolipoproteins: ApoB100, Lp(a) and ApoA in a sample of Mexican children 6-13 years of age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Double blind trial in 600 children 6-13 years of age residing in 12 boarding schools. Schools will be randomized to distribute three types of milk namely: full fat milk (3% fat), partially defatted milk (2% fat) or defatted milk (1% fat) for 90 days of effective exposure (4 months total duration). Subjects will receive 400 mL of the corresponding milk every day (200 mL breakfast and 200 mL night meal) from Monday through Friday. During week ends they will eat a freely chosen diet at home. Milk intake will be measured every day. Diet by 24 h-recall. will be evaluated every month. Blood samples will be obtained at the beginning and at the end of the intervention.

Study Type

Interventional

Enrollment (Actual)

650

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Hidalgo
      • Pachuca, Hidalgo, Mexico
        • Comisíon para el Desarrollo de Pueblos Indigenas

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

6 years to 13 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Attending selected boarding schools

Exclusion Criteria:

  • No lactose intolerance

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Full fat milk
Full fat milk contain 3% fat
Other: Modification of the content of fat in milk
Comparison of three levels of fat content in cow´s milk
Other Names:
  • Liconsa milk
Experimental: Partially defatted milk
Partially defatted milk contains 2% of fat
Other: Modification of the content of cows milk
Comparison of three levels of fat content in cows' milk
Other Names:
  • Liconsa low fat milk
Experimental: Defatted milk
Defatted milk contains 1% fat
Other: Modification of the fat content of cows´ milk
Comparison of three levels of fat content in cow´milk
Other Names:
  • Liconsa defatted milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular risk indicators
Time Frame: 4 months
Cardiovascular risk is indicated by several determinations of blood fats namely: Total cholesterol, triglicerides, Low-density lipoprotein (LDL) and High density lipoprotein (HDL) cholesterol, lipoproteins: Apo a1,Apo B100 and Lp(a)
4 months

Collaborators and Investigators

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

Sponsor

Instituto Nacional de Salud Publica, Mexico

Investigators

  • Principal Investigator: Salvador Villalpando, MD, Ph D, Instituto Nacional de Salud Pública, Mexico
  • Study Chair: Teresa Shamah, M. Sc., Instituto Nacional de Salud Pública, Mexico
  • Study Chair: Yaveth Lara, M Sc, Instituto Nacional de Salud Pública, Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

August 9, 2010

First Submitted That Met QC Criteria

August 9, 2010

First Posted (Estimate)

August 10, 2010

Study Record Updates

Last Update Posted (Estimate)

June 27, 2011

Last Update Submitted That Met QC Criteria

June 24, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Milk, Cardiovas risk, children
  • 1-865-6540 (Other Identifier: Ethics Committee, Instituto Nacional Salud Pub, Mexico)

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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