NCT01516125

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
458

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2019

Completed
Last Updated

November 30, 2023

Status Verified

March 1, 2023

Enrollment Period

7.6 years

First QC Date

January 11, 2012

Last Update Submit

November 29, 2023

Conditions

Healthy

Keywords

healthy adultgenetic variationbotanical oilspolyunsaturated fatty acidfish oilfat metabolismGenetic variation of fat metabolism in healthy adults

Outcome Measures

Primary Outcomes (1)

  • Determine the genotype at the rs174537 single-nucleotide polymorphism (SNP) in the fatty acid desaturate (FADS) gene cluster

    up to 52 months

Study Arms (1)

Screening only - no intervention

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

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.

Study Officials

  • Susan Sergeant, Ph.D.

    Wake Forest University Heath Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2012

First Posted

January 24, 2012

Study Start

September 1, 2011

Primary Completion

April 17, 2019

Study Completion

April 17, 2019

Last Updated

November 30, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

This is a screening (one visit) to recruit healthy people for genotyping and re-contact for future studies

Locations

US(1)