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NCT01418196 · ClinicalTrials.gov registry record
Relation of Diet to Heart Disease Risk Factors in Children
A clinical trial, sponsored by UCSF Benioff Children's Hospital Oakland.
- Completed
- Registry status
- 92
- Enrollment target
NCT01418196: Completed study, sponsored by UCSF Benioff Children's Hospital Oakland.
NCT01418196 is a clinical trial that has completed, run by UCSF Benioff Children's Hospital Oakland. The registered enrollment target is 92 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01418196 has completed, sponsored by UCSF Benioff Children's Hospital Oakland.
- COMPLETED
- Registry status
- 92 participants
- Enrollment target
Study 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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-07 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01418196
The ClinicalTrials.gov registry entry for NCT01418196 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UCSF Benioff Children's Hospital Oakland, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01418196 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01418196 about?
NCT01418196 is a clinical study titled "Relation of Diet to Heart Disease Risk Factors in Children". 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 ca...
What is the current status of trial NCT01418196?
This trial is currently completed. The enrollment target is 92 participants. The study started on 2011-09. Estimated completion is 2013-07.
Who is sponsoring clinical trial NCT01418196?
This trial is sponsored by UCSF Benioff Children's Hospital Oakland, which has 52 total clinical trials registered on ClinicalTrials.gov.
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