Screening of Healthy Adults for Genetic Variations That C... | NCT01516125

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

NCT01516125

Sponsor

Wake Forest University Health Sciences

Status

Completed

Last Update Posted

Nov 30, 2023Actual

Enrollment

458Actual

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
P50AT002782	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011Actual

Primary Completion Date

Apr 17, 2019Actual

Completion Date

Apr 17, 2019Actual

First Submitted Date

Jan 11, 2012

First Submission Date that Met QC Criteria

Jan 18, 2012

First Posted Date

Jan 24, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2023

Last Update Posted Date

Nov 30, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Wake Forest University Health SciencesOTHER

Collaborators

Name	Class
National Center for Complementary and Integrative Health (NCCIH)	NIH
Office of Dietary Supplements (ODS)	NIH
University of Arizona	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

458Actual

Label	Type	Description	Intervention Names
Screening only - no intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susan Sergeant, Ph.D.	Wake Forest University Heath Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wake Forest Health Sciences		Winston-Salem	North Carolina	27157	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Description

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.