Screening of Healthy Adults for Genetic Variations That Control Fatty Acid Processing (No)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by Wake Forest Baptist Health
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Floyd H. Chilton, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier:
NCT01516125
First received: January 11, 2012
Last updated: January 18, 2012
Last verified: January 2012

January 11, 2012
January 18, 2012
September 2011
August 2015   (final data collection date for primary outcome measure)
Determine the genotype at the rs174537 single-nucleotide polymorphism (SNP) in the fatty acid desaturate (FADS) gene cluster [ Time Frame: up to 52 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01516125 on ClinicalTrials.gov Archive Site
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Screening of Healthy Adults for Genetic Variations That Control Fatty Acid Processing
Screening of Healthy Adults for Genetic Variations That Control Fatty Acid Processing

The purpose of this research study is to screen healthy African American and Caucasian persons for specific differences in genes that control how fats are processed in the body. Persons with the needed genotypes will be added to a database of healthy persons who may be asked to join a larger study comparing differences in botanical oil supplements on lipid metabolism and inflammatory biomarkers and future studies. A key hypothesis for the larger study is that variations in genes involved in lipid metabolism play a role in determining levels of long chain polyunsaturated fatty acids (LC-PUFAs).

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

A small saliva sample for screening purposes will be collected. If documentation from a personal physician of blood glucose and lipid levels are unavailable, we will collect a small tube (10-12 ml) of blood to determine these measurements.

Non-Probability Sample

Caucasian or African American adults between 21 and 65 years of age

Healthy
Not Provided
No treatment or intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
August 2015
August 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Be Caucasian or African American between 21-65 years of age
  • Be healthy and free of any major illness
  • Be a nonsmoker
  • Have an intact gallbladder
  • Have TG < 150 and blood pressure less than 130/90

Exclusion Criteria:

  • Not have: myocardial infarction, vascular surgery or stroke within the past year
  • Not be taking niacin, more than 100 mg aspirin/day or montelukast allergy medications
  • BMI equal to or greater than 30 or less than 19
  • Pregnancy
Both
21 Years to 65 Years
Yes
Contact: Priscilla Ivester, M.A. 336-716-7388 ivester@wakehealth.edu
Contact: Tammy C Lee, M.S. 336-716-7388 talee@wakehealth.edu
United States
 
NCT01516125
NCT, P50AT002782
Yes
Floyd H. Chilton, Wake Forest University Baptist Medical Center
Wake Forest Baptist Health
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Floyd (Ski) H Chilton, Ph.D. Wake Forest University Heath Sciences
Wake Forest Baptist Health
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP