Sponsor study identifier
observational
92
1 country
1
Study Start
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2012
Actual (reported)Study Completion
July 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2013
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 15, 2011
Actual (reported)August 17, 2011
Actual (reported)September 2011
Date type not reportedThis date has not been verified as actual or estimated.
April 2012
Actual (reported)July 2013
Actual (reported)Trimethylamine N-oxide (TMAO)
1 time
Choline
1 time
LDL subfractions
1 time
HDL cholesterol
1 time
Triglycerides
1 time
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.
Children's Hospital & Research Center Oakland
Oakland, California, 94609, United States
Ronald M Krauss, MD
UCSF Benioff Children's Hospital Oakland
92 participants (actual enrollment reported by the registry).
First Submitted
August 15, 2011
First Posted
August 17, 2011
Study Start
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
"Multifactorial Risk Stratification in Acute and Chronic Cardiovascular Disease"
Contact the study team to confirm eligibility.
Primary Completion
April 2012
Actual (reported)Study Completion
July 2013
Actual (reported)Last Updated
March 26, 2015
Record last verified: 2015-03
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Source: ClinicalTrials.gov.
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