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Screening of Healthy Adults for Genetic Variations That Control Fatty Acid Processing

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Wake Forest University Health Sciences
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Floyd (Ski) H. Chilton, Ph.D., Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT01516125
First received: January 11, 2012
Last updated: January 9, 2017
Last verified: January 2017

January 11, 2012
January 9, 2017
September 2011
December 2019   (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 ]
Same as current
Complete list of historical versions of study NCT01516125 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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.
Healthy African American and Caucasian persons will be screened 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 diet on lipid metabolism and inflammatory biomarkers as well as 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).
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
Screening only - no 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
July 2020
December 2019   (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
  • Must be willing to be re-contacted for future studies

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
  • Fasting glucose greater than 125 mg/dl
  • Pregnancy
Sexes Eligible for Study: All
21 Years to 65 Years   (Adult)
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 ( US NIH Grant/Contract Award Number )
Yes
Not Provided
No
This is a screening (one visit) to recruit healthy people for genotyping and re-contact for future studies
Floyd (Ski) H. Chilton, Ph.D., Wake Forest University Health Sciences
Wake Forest University Health Sciences
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Floyd (Ski) H Chilton, Ph.D. Wake Forest University Heath Sciences
Wake Forest University Health Sciences
January 2017

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