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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Attending selected boarding schools Exclusion Criteria: No lactose intolerance

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Full fat milk<br>Full fat milk contain 3% fat | Other: Modification of the content of fat in milk<br>* Comparison of three levels of fat content in cow´s milk<br>* Other names: Liconsa milk;|
| Experimental: Partially defatted milk<br>Partially defatted milk contains 2% of fat | Other: Modification of the content of cows milk<br>* Comparison of three levels of fat content in cows' milk<br>* Other names: Liconsa low fat milk;|
| Experimental: Defatted milk<br>Defatted milk contains 1% fat | Other: Modification of the fat content of cows´ milk<br>* Comparison of three levels of fat content in cow´milk<br>* Other names: Liconsa defatted milk;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular risk indicators | 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) | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidemiological risk, diet, fat intake