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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01178515
Enrollment
650
Registered
2010-08-10
Start date
2010-09-30
Completion date
2011-05-31
Last updated
2011-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

epidemiological risk, diet, fat intake

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.

Interventions

OTHERModification of the content of fat in milk

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

OTHERModification of the content of cows milk

Comparison of three levels of fat content in cows' milk

OTHERModification of the fat content of cows´ milk

Comparison of three levels of fat content in cow´milk

Sponsors

Instituto Nacional de Salud Publica, Mexico
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
6 Years to 13 Years
Healthy volunteers
Yes

Inclusion criteria

* Attending selected boarding schools

Exclusion criteria

* No lactose intolerance

Design outcomes

Primary

MeasureTime frameDescription
Cardiovascular risk indicators4 monthsCardiovascular 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)

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026