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

This study has been completed.
Sponsor:
Information provided by:
Instituto Nacional de Salud Publica, Mexico
ClinicalTrials.gov Identifier:
NCT01178515
First received: August 9, 2010
Last updated: June 24, 2011
Last verified: June 2011
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Impact of Low Fat Milk Intake on Cardiovascular Risk Indicators in Children 6-13 Years of Age

Further study details as provided by Instituto Nacional de Salud Publica, Mexico:

Primary Outcome Measures:
  • Cardiovascular risk indicators [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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)


Enrollment: 650
Study Start Date: September 2010
Study Completion Date: May 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   6 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Attending selected boarding schools

Exclusion Criteria:

  • No lactose intolerance
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
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
Study First Received: August 9, 2010
Last Updated: June 24, 2011
Health Authority: Mexico: National Institute of Public Health, Health Secretariat

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

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 19, 2014