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

This study is currently recruiting participants.
Verified May 2017 by Wake Forest University Health Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT01516125
First Posted: January 24, 2012
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  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.

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 University Health Sciences:

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 ]

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: July 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
Screening only - no intervention

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).
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 Submitted: January 11, 2012
First Posted: January 24, 2012
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