Low Fat Milk Intake and Cardio Vascular Risk (CVR) Indicators in Children - Full Text View

Purpose

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.

Condition	Intervention	Phase
Cardiovascular Diseases	Other: Modification of the content of fat in milk Other: Modification of the content of cows milk Other: Modification of the fat content of cows´ milk	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Official Title:	Impact of Low Fat Milk Intake on Cardiovascular Risk Indicators in Children 6-13 Years of Age

Further study details as provided by Instituto Nacional de Salud Publica, Mexico:

Primary Outcome Measures:

Cardiovascular risk indicators [ Time Frame: 4 months ] [ Designated as safety issue: No ]
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)

Enrollment:	650
Study Start Date:	September 2010
Study Completion Date:	May 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sham Comparator: Full fat milk Full fat milk contain 3% fat	Other: Modification of the content of fat in milk Comparison of three levels of fat content in cow´s milk Other Name: Liconsa milk
Experimental: Partially defatted milk Partially defatted milk contains 2% of fat	Other: Modification of the content of cows milk Comparison of three levels of fat content in cows' milk Other Name: Liconsa low fat milk
Experimental: Defatted milk Defatted milk contains 1% fat	Other: Modification of the fat content of cows´ milk Comparison of three levels of fat content in cow´milk Other Name: Liconsa defatted milk

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

Ages Eligible for Study:	6 Years to 13 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Attending selected boarding schools

Exclusion Criteria:

No lactose intolerance

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01178515

Locations

Mexico
Comisíon para el Desarrollo de Pueblos Indigenas
Pachuca, Hidalgo, Mexico

Sponsors and Collaborators

Instituto Nacional de Salud Publica, Mexico

Investigators

Principal Investigator:	Salvador Villalpando, MD, Ph D	Instituto Nacional de Salud Publica, Mexico
Study Chair:	Teresa Shamah, M. Sc.	Instituto Nacional de Salud Publica, Mexico
Study Chair:	Yaveth Lara, M Sc	Instituto Nacional de Salud Publica, Mexico

More Information

Publications:

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.

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.

Freedman DS. Clustering of coronary heart disease risk factors among obese children. J Pediatr Endocrinol Metab. 2002 Sep-Oct;15(8):1099-108.

Aguilar-Salinas CA, Gómez Pérez FJ, Rull Rodrigo J, Villalpando S, Barquera S, Rojas R. Prevalence of dyslipidemias in the 2006 Encuesta Nacional de Salud y Nutrición. Salud Pub Mex, 2010; 52 Sppl 1: S44-S53.

Corvalán 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. Epub 2009 Nov 18.

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.

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.

Responsible Party:	Dr. Salvador Villalpando, Instituto Nacional de Salud Publica
ClinicalTrials.gov Identifier:	NCT01178515 History of Changes
Other Study ID Numbers:	Milk, Cardiovas risk, children, 1-865-6540
Study First Received:	August 9, 2010
Last Updated:	June 24, 2011
Health Authority:	Mexico: National Institute of Public Health, Health Secretariat

Keywords provided by Instituto Nacional de Salud Publica, Mexico:

epidemiological risk
diet
fat intake

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 17, 2012