Relation of Diet to Heart Disease Risk Factors in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01418196
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : March 26, 2015
Information provided by (Responsible Party):
Children's Hospital & Research Center Oakland

Brief 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.

Condition or disease
Healthy Cardiovascular Disease

Detailed Description:

From interested participants (children and parents) we will obtain:

  1. Informed consent
  2. Anthropometric measurements - height, weight, waist and hip circumference, blood pressure, % body fat by bioimpedance (Tanita scale).
  3. Health History Questionnaire
  4. Food Frequency Questionnaire
  5. 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
Observational Model: Family-Based
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Primary Outcome Measures :
  1. Trimethylamine N-oxide (TMAO) [ Time Frame: 1 time ]

Secondary Outcome Measures :
  1. Choline [ Time Frame: 1 time ]
  2. LDL subfractions [ Time Frame: 1 time ]
  3. HDL cholesterol [ Time Frame: 1 time ]
  4. Triglycerides [ Time Frame: 1 time ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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.

Inclusion Criteria:

  • Children >7 years of age and their parents

Exclusion Criteria:

  • Antibiotics
  • Pregnant or breastfeeding women

Information from the National Library of Medicine

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 identifier (NCT number): NCT01418196

United States, California
Children's Hospital & Research Center Oakland
Oakland, California, United States, 94609
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
Principal Investigator: Ronald M Krauss, MD Children's Hospital & Research Center Oakland

Responsible Party: Children's Hospital & Research Center Oakland Identifier: NCT01418196     History of Changes
Other Study ID Numbers: MM-3462
First Posted: August 17, 2011    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by Children's Hospital & Research Center Oakland:
Dietary choline
Cardiovascular disease risk
Atherogenic dyslipidemia

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases