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Completed

NCT Number: NCT01178515

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

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.

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Key information

Conditions

Cardiovascular Diseases

Age range

6 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Comisíon para el Desarrollo de Pueblos Indigenas

Pachuca, Hidalgo, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Attending selected boarding schools

Exclusion criteria

  • No lactose intolerance

Treatment and study plan

Modification of the content of fat in milk

Other

Comparison of three levels of fat content in cow´s milk

Other names: Liconsa milk

Modification of the content of cows milk

Other

Comparison of three levels of fat content in cows' milk

Other names: Liconsa low fat milk

Modification of the fat content of cows´ milk

Other

Comparison of three levels of fat content in cow´milk

Other names: Liconsa defatted milk

Primary outcomes

  1. Cardiovascular risk indicators

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Salud Publica, Mexico

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 10, 2010
Registry last updated
Jun 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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