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

Phase 4

Completed

• Conditions: Cardiovascular Diseases
• Interventions: 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

• Registration Number: NCT01178515
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2010-08-09
• Study First Submitted QC: 2010-08-09
• Study First Posted: 2010-08-10
• Study Start: 2010-09
• Primary Completion: 2011-02
• Study Completion: 2011-05
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-24
• Last Update Posted: 2011-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

• Attending selected boarding schools

Exclusion Criteria

• No lactose intolerance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Full fat milk	Modification of the content of fat in milk	Full fat milk contain 3% fat
Partially defatted milk	Modification of the content of cows milk	Partially defatted milk contains 2% of fat
Defatted milk	Modification of the fat content of cows´ milk	Defatted milk contains 1% fat

Primary Outcome Measures

Name	Time	Method
Cardiovascular risk indicators	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)

Trial Locations

Locations (1)

Comisíon para el Desarrollo de Pueblos Indigenas; 🇲🇽 Pachuca, Hidalgo, Mexico