Relation of Diet to Heart Disease Risk Factors in Children

NCT01418196 | Completed DMC

• 1 other identifier: MM-3462
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

Metabolites of dietary phosphatidylcholine- choline and trimethylamine N-oxide (TMAO)- were recently identified as being associated with myocardial infarction in a case-control study. The latter TMAO is a gut-microflora-derived choline metabolite that has been shown to be a potent risk factor for cardiovascular disease (CVD). This pilot study seeks to use information derived from a dietary questionnaire in children to test the association of dietary choline intake to plasma levels of TMAO as well as the relationship between plasma choline levels and components of atherogenic dyslipidemia (increased triglycerides and small LDL, and reduced HDL cholesterol). An ancillary goal of this study is to build on existing programs of community outreach to local Oakland/Berkeley minority communities, and to develop an infrastructure for family-based and community participation in clinical research across the full age spectrum and among diverse populations. This pilot study will examine the association of dietary choline intake assessed by food frequency questionnaires to biomarkers of CVD risk in 40 children (\> 7 years of age) and their parents as there is no information regarding this relationship in children. The results of this pilot study will form the basis for a proposal to carry out a randomized intervention trial to directly test the effects of dietary choline intake on plasma TMAO and lipoprotein levels. Ultimately, better understanding of the relationship between dietary choline intake and CVD risk factors may facilitate the formulation of appropriate dietary choline recommendations in children and adults.

Conditions

Healthy; Cardiovascular Disease

Keywords

TMAO; Children; Dietary choline; Cardiovascular disease risk; Atherogenic dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Trimethylamine N-oxide (TMAO)

  1 time

Secondary Outcomes (4)

• Choline

  1 time

• LDL subfractions

  1 time

• HDL cholesterol

  1 time

• Triglycerides

  1 time

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will consist of children (\>7 years of age) and their parents who are generally healthy. Parents are not required to participant in the study. We will include all ethnicities.

You may qualify if:

• Children \>7 years of age and their parents

You may not qualify if:

• Antibiotics
• Pregnant or breastfeeding women

Sponsors & Collaborators

• UCSF Benioff Children's Hospital Oakland: lead

Study Sites (1)

Children's Hospital & Research Center Oakland

Oakland, California, 94609, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Ronald M Krauss, MD

  UCSF Benioff Children's Hospital Oakland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: August 17, 2011
• Study Start: September 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: July 1, 2013
• Last Updated: March 26, 2015

Record last verified: 2015-03

Locations

US (1)