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

NCT01178515 | Completed Phase 4 DMC

• 2 other identifiers: Milk, Cardiovas risk, children1-865-6540
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

epidemiological risk; diet; fat intake

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Full fat milk

SHAM COMPARATOR

Full fat milk contain 3% fat

Other: Modification of the content of fat in milk

Partially defatted milk

EXPERIMENTAL

Partially defatted milk contains 2% of fat

Other: Modification of the content of cows milk

Defatted milk

EXPERIMENTAL

Defatted milk contains 1% fat

Other: Modification of the fat content of cows´ milk

Interventions

Modification of the content of fat in milk OTHER

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

Also known as: Liconsa milk

Full fat milk

Modification of the content of cows milk OTHER

Comparison of three levels of fat content in cows' milk

Also known as: Liconsa low fat milk

Partially defatted milk

Modification of the fat content of cows´ milk OTHER

Comparison of three levels of fat content in cow´milk

Also known as: Liconsa defatted milk

Defatted milk

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Attending selected boarding schools

You may not qualify if:

• No lactose intolerance

Sponsors & Collaborators

• Instituto Nacional de Salud Publica, Mexico: lead

Study Sites (1)

Comisíon para el Desarrollo de Pueblos Indigenas

Pachuca, Hidalgo, Mexico

Location

Related Publications (7)

• 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.

  PMID: 18563960 BACKGROUND

• 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.

  PMID: 9614255 BACKGROUND

• 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.

  PMID: 12387507 BACKGROUND

• 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.

  PMID: 20585729 BACKGROUND

• 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.

  PMID: 19923378 BACKGROUND

• 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.

  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.

  PMID: 2028978 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Milk

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Salvador Villalpando, MD, Ph D

  Instituto Nacional de Salud Publica, Mexico

  PRINCIPAL INVESTIGATOR

• Teresa Shamah, M. Sc.

  Instituto Nacional de Salud Publica, Mexico

  STUDY CHAIR

• Yaveth Lara, M Sc

  Instituto Nacional de Salud Publica, Mexico

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 9, 2010
• First Posted: August 10, 2010
• Study Start: September 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 27, 2011

Record last verified: 2011-06

Locations

ME (1)