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

Cardiovascular Diseases Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases

• NCT number: NCT01178515
• Study type: Interventional
• Source: Instituto Nacional de Salud Publica, Mexico
• Status: Completed
• Phase: Phase 4
• Start date: September 2010
• Completion date: May 2011