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

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ClinicalTrials.gov Identifier: NCT01178515
Recruitment Status : Completed
First Posted : August 10, 2010
Last Update Posted : June 27, 2011
Sponsor:
Information provided by:
Instituto Nacional de Salud Publica, Mexico

August 9, 2010
August 10, 2010
June 27, 2011
September 2010
February 2011   (Final data collection date for primary outcome measure)
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)
Cardiovascular risk indicators [ Time Frame: 4 months ]
Cardiovascular risk is indicated by several determinations of blood fats namely: Total cholesterol triglicerides, LDL y HDL cholesterol, lipoproteins Apo a1,Apo B100 and Lp(a)
Complete list of historical versions of study NCT01178515 on ClinicalTrials.gov Archive Site
Not Provided
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Low Fat Milk Intake and Cardio Vascular Risk (CVR) Indicators in Children
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Cardiovascular Diseases
  • Other: Modification of the content of fat in milk
    Comparison of three levels of fat content in cow´s milk
    Other Name: Liconsa milk
  • Other: Modification of the content of cows milk
    Comparison of three levels of fat content in cows' milk
    Other Name: Liconsa low fat milk
  • Other: Modification of the fat content of cows´ milk
    Comparison of three levels of fat content in cow´milk
    Other Name: Liconsa defatted milk
  • Sham Comparator: Full fat milk
    Full fat milk contain 3% fat
    Intervention: Other: Modification of the content of fat in milk
  • Experimental: Partially defatted milk
    Partially defatted milk contains 2% of fat
    Intervention: Other: Modification of the content of cows milk
  • Experimental: Defatted milk
    Defatted milk contains 1% fat
    Intervention: Other: Modification of the fat content of cows´ milk

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
650
600
May 2011
February 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Attending selected boarding schools

Exclusion Criteria:

  • No lactose intolerance
Sexes Eligible for Study: All
6 Years to 13 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Mexico
 
 
NCT01178515
Milk, Cardiovas risk, children
1-865-6540 ( Other Identifier: Ethics Committee, Instituto Nacional Salud Pub, Mexico )
Yes
Not Provided
Not Provided
Dr. Salvador Villalpando, Instituto Nacional de Salud Publica
Instituto Nacional de Salud Publica, Mexico
Not Provided
Principal Investigator: Salvador Villalpando, MD, Ph D Instituto Nacional de Salud Publica, Mexico
Study Chair: Teresa Shamah, M. Sc. Instituto Nacional de Salud Publica, Mexico
Study Chair: Yaveth Lara, M Sc Instituto Nacional de Salud Publica, Mexico
Instituto Nacional de Salud Publica, Mexico
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP