Clinical trial NCT01178515: Low Fat Milk Intake and Cardio Vascular Risk (CVR) Indicators in Children
Official title: Impact of Low Fat Milk Intake on Cardiovascular Risk Indicators in Children 6-13 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Diseases
Keywords: epidemiological risk
diet
fat intake
Lead sponsor: Instituto Nacional de Salud Publica, Mexico
Sponsor class: OTHER
First posted: 2010-08-10
Enrollment: 650
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Attending selected boarding schools

Exclusion Criteria:

* No lactose intolerance

Primary outcomes:
measure: Cardiovascular risk indicators
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pachuca
country: Mexico
facility: Comisíon para el Desarrollo de Pueblos Indigenas
state: Hidalgo
Study officials:
affiliation: Instituto Nacional de Salud Publica, Mexico
name: Salvador Villalpando, MD, Ph D
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Salud Publica, Mexico
name: Teresa Shamah, M. Sc.
role: STUDY_CHAIR
affiliation: Instituto Nacional de Salud Publica, Mexico
name: Yaveth Lara, M Sc
role: STUDY_CHAIR
References:
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citation: Freedman DS. Clustering of coronary heart disease risk factors among obese children. J Pediatr Endocrinol Metab. 2002 Sep-Oct;15(8):1099-108. doi: 10.1515/JPEM.2002.15.8.1099.
citation: Aguilar-Salinas CA, Gomez-Perez FJ, Rull J, Villalpando S, Barquera S, Rojas R. Prevalence of dyslipidemias in the Mexican National Health and Nutrition Survey 2006. Salud Publica Mex. 2010;52 Suppl 1:S44-53. doi: 10.1590/s0036-36342010000700008.
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citation: Villalpando S, Carrión C, Barquera S, Olaiz G, Robledo R. The body mass index is associated with hyperglycemia and alterations of some components of the metabolic syndrome in Mexican adolescents aged 10-19 years. Salud Pub Mex 2007; 49:s324-s330.
citation: Webber LS, Srinivasan SR, Wattigney WA, Berenson GS. Tracking of serum lipids and lipoproteins from childhood to adulthood. The Bogalusa Heart Study. Am J Epidemiol. 1991 May 1;133(9):884-99. doi: 10.1093/oxfordjournals.aje.a115968.