- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01418196
Relation of Diet to Heart Disease Risk Factors in Children
Study Overview
Status
Conditions
Detailed Description
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
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Oakland, California, United States, 94609
- Children's Hospital & Research Center Oakland
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children >7 years of age and their parents
Exclusion Criteria:
- Antibiotics
- Pregnant or breastfeeding women
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Trimethylamine N-oxide (TMAO)
Time Frame: 1 time
|
1 time
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Choline
Time Frame: 1 time
|
1 time
|
LDL subfractions
Time Frame: 1 time
|
1 time
|
HDL cholesterol
Time Frame: 1 time
|
1 time
|
Triglycerides
Time Frame: 1 time
|
1 time
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MM-3462
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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