Relation of Diet to Heart Disease Risk Factors in Children
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|ClinicalTrials.gov Identifier: NCT01418196|
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : March 26, 2015
|Condition or disease|
|Healthy Cardiovascular Disease|
From interested participants (children and parents) we will obtain:
- Informed consent
- Anthropometric measurements - height, weight, waist and hip circumference, blood pressure, % body fat by bioimpedance (Tanita scale).
- Health History Questionnaire
- Food Frequency Questionnaire
- Fasting blood sample- We will collect a total of 40 ml of blood (less than 3 ml/kg for the entire study). The blood samples will be used to measure triglyceride, LDL-cholesterol, HDL-cholesterol, glucose, insulin, apoA1, apoB, C-reactive protein, lipoprotein subfraction analysis by ion mobility, DNA for inclusion in our DNA biobank, choline, TMAO and other metabolites related to heart disease risk.
Standard Blood sampling: Using standard blood collection procedures, blood samples will be collected from participants after a 12-14 hour fast. The blood will be collected in tubes containing the following preservative solution: 3.0 gms EDTA (dipotassium), 1.7 mg P-Pack, 0.15 gms gentamycin sulfate, 0.15 gms chloramphenicol, 5.96 mls aprotinin (Sigma A-6279), and 0.30 gms sodium azide all of which are diluted to 20mls with doubly deionized water. Plasma is separated by immediate centrifugation at 4°C. Lipid and lipoprotein measurements are performed and aliquots of plasma are frozen for future analyses.
|Study Type :||Observational|
|Actual Enrollment :||92 participants|
|Official Title:||Relation of Diet to Heart Disease Risk Factors in Children|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||July 2013|
- Trimethylamine N-oxide (TMAO) [ Time Frame: 1 time ]
- Choline [ Time Frame: 1 time ]
- LDL subfractions [ Time Frame: 1 time ]
- HDL cholesterol [ Time Frame: 1 time ]
- Triglycerides [ Time Frame: 1 time ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418196
|United States, California|
|Children's Hospital & Research Center Oakland|
|Oakland, California, United States, 94609|
|Principal Investigator:||Ronald M Krauss, MD||Children's Hospital & Research Center Oakland|