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

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ClinicalTrials.gov Identifier: NCT01516125
Recruitment Status : Recruiting
First Posted : January 24, 2012
Last Update Posted : November 8, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Healthy

Detailed Description:
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).

Study Design

Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Screening of Healthy Adults for Genetic Variations That Control Fatty Acid Processing
Study Start Date : September 2011
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : July 2020
Groups and Cohorts

Group/Cohort
Screening only - no intervention


Outcome Measures

Primary Outcome Measures :
  1. Determine the genotype at the rs174537 single-nucleotide polymorphism (SNP) in the fatty acid desaturate (FADS) gene cluster [ Time Frame: up to 52 months ]

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
  • 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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): 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 University Health Sciences
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Investigators
Principal Investigator: Floyd (Ski) H Chilton, Ph.D. Wake Forest University Heath Sciences
More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01516125     History of Changes
Other Study ID Numbers: IRB00016822
P50AT002782 ( U.S. NIH Grant/Contract )
First Posted: January 24, 2012    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is a screening (one visit) to recruit healthy people for genotyping and re-contact for future studies

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