Relation of Diet to Heart Disease Risk Factors in Children
|Study Design:||Observational Model: Family-Based
Time Perspective: Cross-Sectional
|Official Title:||Relation of Diet to Heart Disease Risk Factors in Children|
- Trimethylamine N-oxide (TMAO) [ Time Frame: 1 time ] [ Designated as safety issue: No ]
- Choline [ Time Frame: 1 time ] [ Designated as safety issue: No ]
- LDL subfractions [ Time Frame: 1 time ] [ Designated as safety issue: No ]
- HDL cholesterol [ Time Frame: 1 time ] [ Designated as safety issue: No ]
- Triglycerides [ Time Frame: 1 time ] [ Designated as safety issue: No ]
|Study Start Date:||September 2011|
|Study Completion Date:||July 2013|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|