A Phase 4 interventional study of Modification of the content of fat in milk and Modification of the content of cows milk in Cardiovascular Diseases, sponsored by Instituto Nacional de Salud Publica, Mexico. Completed at 1 site in Mexico. Open to participants aged 6 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-27.
Sponsored by Instituto Nacional de Salud Publica, Mexico · Phase 4, Interventional, and Prevention
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.
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 650 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Instituto Nacional de Salud Publica, Mexico is the lead sponsor of 30 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Full fat milk contain 3% fat
Other: Modification of the content of fat in milk
Partially defatted milk contains 2% of fat
Other: Modification of the content of cows milk
Defatted milk contains 1% fat
Other: Modification of the fat content of cows´ milk
Comparison of three levels of fat content in cow´s milk
Also known as: Liconsa milk
Comparison of three levels of fat content in cows' milk
Also known as: Liconsa low fat milk
Comparison of three levels of fat content in cow´milk
Also known as: Liconsa defatted milk
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)
Time frame: 4 months
This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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Instituto Nacional de Salud Publica, Mexico