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

NCT ID: NCT01178515

Last Updated: 2011-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-05-31

Brief Summary

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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

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Full fat milk

Full fat milk contain 3% fat

Group Type SHAM_COMPARATOR

Modification of the content of fat in milk

Intervention Type OTHER

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

Partially defatted milk

Partially defatted milk contains 2% of fat

Group Type EXPERIMENTAL

Modification of the content of cows milk

Intervention Type OTHER

Comparison of three levels of fat content in cows' milk

Defatted milk

Defatted milk contains 1% fat

Group Type EXPERIMENTAL

Modification of the fat content of cows´ milk

Intervention Type OTHER

Comparison of three levels of fat content in cow´milk

Interventions

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Modification of the content of fat in milk

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

Intervention Type OTHER

Modification of the content of cows milk

Comparison of three levels of fat content in cows' milk

Intervention Type OTHER

Modification of the fat content of cows´ milk

Comparison of three levels of fat content in cow´milk

Intervention Type OTHER

Other Intervention Names

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Liconsa milk Liconsa low fat milk Liconsa defatted milk

Eligibility Criteria

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Inclusion Criteria

* Attending selected boarding schools

Exclusion Criteria

* No lactose intolerance
Minimum Eligible Age

6 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Nacional de Salud Publica, Mexico

OTHER

Sponsor Role lead

Responsible Party

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Instituto Nacional de Salud Publica

Principal Investigators

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Salvador Villalpando, MD, Ph D

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Salud Publica, Mexico

Teresa Shamah, M. Sc.

Role: STUDY_CHAIR

Instituto Nacional de Salud Publica, Mexico

Yaveth Lara, M Sc

Role: STUDY_CHAIR

Instituto Nacional de Salud Publica, Mexico

Locations

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Comisíon para el Desarrollo de Pueblos Indigenas

Pachuca, Hidalgo, Mexico

Site Status

Countries

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Mexico

References

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Stevens G, Dias RH, Thomas KJ, Rivera JA, Carvalho N, Barquera S, Hill K, Ezzati M. Characterizing the epidemiological transition in Mexico: national and subnational burden of diseases, injuries, and risk factors. PLoS Med. 2008 Jun 17;5(6):e125. doi: 10.1371/journal.pmed.0050125.

Reference Type BACKGROUND
PMID: 18563960 (View on PubMed)

Berenson GS, Srinivasan SR, Bao W, Newman WP 3rd, Tracy RE, Wattigney WA. Association between multiple cardiovascular risk factors and atherosclerosis in children and young adults. The Bogalusa Heart Study. N Engl J Med. 1998 Jun 4;338(23):1650-6. doi: 10.1056/NEJM199806043382302.

Reference Type BACKGROUND
PMID: 9614255 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12387507 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20585729 (View on PubMed)

Corvalan C, Uauy R, Kain J, Martorell R. Obesity indicators and cardiometabolic status in 4-y-old children. Am J Clin Nutr. 2010 Jan;91(1):166-74. doi: 10.3945/ajcn.2009.27547. Epub 2009 Nov 18.

Reference Type BACKGROUND
PMID: 19923378 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 2028978 (View on PubMed)

Other Identifiers

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1-865-6540

Identifier Type: OTHER

Identifier Source: secondary_id

Milk, Cardiovas risk, children

Identifier Type: -

Identifier Source: org_study_id

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