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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 458

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Screening only - no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determine the genotype at the rs174537 single-nucleotide polymorphism (SNP) in the fatty acid desaturate (FADS) gene cluster	up to 52 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); University of Arizona; Office of Dietary Supplements (ODS)
• Investigators: Principal Investigator: Susan Sergeant, Ph.D., Wake Forest University Heath Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2011
• Primary Completion (Actual): April 17, 2019
• Study Completion (Actual): April 17, 2019

Study Registration Dates

• First Submitted: January 11, 2012
• First Submitted That Met QC Criteria: January 18, 2012
• First Posted (Estimated): January 24, 2012

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: fish oil; healthy adult; genetic variation; botanical oils; polyunsaturated fatty acid; fat metabolism; Genetic variation of fat metabolism in healthy adults
• Other Study ID Numbers: IRB00016822; P50AT002782 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a screening (one visit) to recruit healthy people for genotyping and re-contact for future studies

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No