Relation of Diet to Heart Disease Risk Factors in Children

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT01418196
First received: August 15, 2011
Last updated: January 10, 2013
Last verified: January 2013
  Purpose

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
Healthy
Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: Relation of Diet to Heart Disease Risk Factors in Children

Resource links provided by NLM:


Further study details as provided by Children's Hospital & Research Center Oakland:

Primary Outcome Measures:
  • Trimethylamine N-oxide (TMAO) [ Time Frame: 1 time ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: September 2011
Estimated Study Completion Date: July 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

  • Children >7 years of age and their parents

Exclusion Criteria:

  • Antibiotics
  • Pregnant or breastfeeding women
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01418196

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

No publications provided

Responsible Party: Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier: NCT01418196     History of Changes
Other Study ID Numbers: MM-3462
Study First Received: August 15, 2011
Last Updated: January 10, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on August 18, 2014