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

Secretariat of Health

Status and phase: Completed; Phase 4

Conditions: Cardiovascular Diseases

Treatments: Other: Modification of the fat content of cows´ milk; Other: Modification of the content of fat in milk; Other: Modification of the content of cows milk

Study type: Interventional

Funder types: Other

Identifiers

NCT01178515

1-865-6540 (Other Identifier)

Milk, Cardiovas risk, children

Details and patient eligibility

About

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.

Full 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.

Enrollment: 650 patients

Sex: All

Ages: 6 to 13 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Attending selected boarding schools

Exclusion criteria

• No lactose intolerance

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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650 participants in 3 patient groups

Full fat milk

Sham Comparator group

Description:

Full fat milk contain 3% fat

Treatment:

Other: Modification of the content of fat in milk

Partially defatted milk

Experimental group

Description:

Partially defatted milk contains 2% of fat

Treatment:

Other: Modification of the content of cows milk

Defatted milk

Experimental group

Description:

Defatted milk contains 1% fat

Treatment:

Other: Modification of the fat content of cows´ milk