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
  Purpose

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).


Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Screening of Healthy Adults for Genetic Variations That Control Fatty Acid Processing

Further study details as provided by Wake Forest Baptist Health:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

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.


Estimated Enrollment: 800
Study Start Date: September 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
No treatment or intervention

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  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: NCT01516125

Contacts
Contact: Priscilla Ivester, M.A. 336-716-7388 ivester@wakehealth.edu
Contact: Tammy C Lee, M.S. 336-716-7388 talee@wakehealth.edu

Locations
United States, North Carolina
Wake Forest Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Priscilla Ivester, M.A.    336-716-7388    ivester@wakehealth.edu   
Contact: Tammy Lee, M.S.    336-716-7388    talee@wakehealth.edu   
Principal Investigator: Floyd (Ski) H. Chilton, Ph.D.         
Sponsors and Collaborators
Wake Forest Baptist Health
Investigators
Principal Investigator: Floyd (Ski) H Chilton, Ph.D. Wake Forest University Heath Sciences
  More Information

No publications provided

Responsible Party: Floyd H. Chilton, Director of 'The Center for Botanical Lipids and Inflammatory Disease Prevention', Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier: NCT01516125     History of Changes
Other Study ID Numbers: NCT, P50AT002782
Study First Received: January 11, 2012
Last Updated: January 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest Baptist Health:
healthy adult
genetic variation
botanical oils
polyunsaturated fatty acid
fish oil
fat metabolism
Genetic variation of fat metabolism in healthy adults

ClinicalTrials.gov processed this record on July 26, 2014