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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01178515
• Other study ID #: Milk, Cardiovas risk, children
• Secondary ID: 1-865-6540
• Status: Completed
• Phase: Phase 4
• First received: August 9, 2010
• Last updated: June 24, 2011
• Start date: September 2010
• Est. completion date: May 2011

Study information

• Verified date: June 2011
• Source: Instituto Nacional de Salud Publica, Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: National Institute of Public Health, Health Secretariat
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: May 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 13 Years

Eligibility

Inclusion Criteria:

• Attending selected boarding schools

Exclusion Criteria:

• No lactose intolerance

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Other:
• Modification of the content of fat in milk
Comparison of three levels of fat content in cow´s milk
• Modification of the content of cows milk
Comparison of three levels of fat content in cows' milk
• Modification of the fat content of cows´ milk
Comparison of three levels of fat content in cow´milk

Locations

Country	Name	City	State
Mexico	Comisíon para el Desarrollo de Pueblos Indigenas	Pachuca	Hidalgo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Salud Publica, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (7)

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.

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. — View Citation

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. doi: 10.3945/ajcn.2009.27547. Epub 2009 Nov 18. — View Citation

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

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. — View 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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular risk indicators	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)	4 months	No