NCT01178515

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 650 (actual)
• Sponsor: Instituto Nacional de Salud Publica, Mexico · Academic / Other
• Sex: All
• Age: 6 Years – 13 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
OTHER	Modification of the content of fat in milk	Comparison of three levels of fat content in cow´s milk
OTHER	Modification of the content of cows milk	Comparison of three levels of fat content in cows' milk
OTHER	Modification of the fat content of cows´ milk	Comparison of three levels of fat content in cow´milk

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-02-01
• Completion: 2011-05-01
• First posted: 2010-08-10
• Last updated: 2011-06-27

Locations

1 site across 1 country: Mexico