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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Other: Modification of the content of fat in milk Other: Modification of the content of cows milk Other: Modification of the fat content of cows´ milk Phase 4

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  (Clinical Trial)
Actual Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Impact of Low Fat Milk Intake on Cardiovascular Risk Indicators in Children 6-13 Years of Age
Study Start Date : September 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : May 2011

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 Name: 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 Name: 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 Name: Liconsa defatted milk




Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   6 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Attending selected boarding schools

Exclusion Criteria:

  • No lactose intolerance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01178515


Locations
Mexico
Comisíon para el Desarrollo de Pueblos Indigenas
Pachuca, Hidalgo, Mexico
Sponsors and Collaborators
Instituto Nacional de Salud Publica, Mexico
Investigators
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

Publications:
Aguilar-Salinas CA, Gómez Pérez FJ, Rull Rodrigo J, Villalpando S, Barquera S, Rojas R. Prevalence of dyslipidemias in the 2006 Encuesta Nacional de Salud y Nutrición. Salud Pub Mex, 2010; 52 Sppl 1: S44-S53.
Villalpando S, Carrión C, Barquera S, Olaiz G, Robledo R. The body mass index is associated with hyperglycemia and alterations of some components of the metabolic syndrome in Mexican adolescents aged 10-19 years. Salud Pub Mex 2007; 49:s324-s330.

Responsible Party: Dr. Salvador Villalpando, Instituto Nacional de Salud Publica
ClinicalTrials.gov Identifier: NCT01178515     History of Changes
Other Study ID Numbers: Milk, Cardiovas risk, children
1-865-6540 ( Other Identifier: Ethics Committee, Instituto Nacional Salud Pub, Mexico )
First Posted: August 10, 2010    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011

Keywords provided by Instituto Nacional de Salud Publica, Mexico:
epidemiological risk
diet
fat intake

Additional relevant MeSH terms:
Cardiovascular Diseases