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

NCT ID: NCT01516125

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

458 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2019-04-17

Brief Summary

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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

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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).

Conditions

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Healthy

Keywords

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healthy adult genetic variation botanical oils polyunsaturated fatty acid fish oil fat metabolism Genetic variation of fat metabolism in healthy adults

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Screening only - no intervention

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Office of Dietary Supplements (ODS)

NIH

Sponsor Role collaborator

University of Arizona

OTHER

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan Sergeant, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Heath Sciences

Locations

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Wake Forest Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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P50AT002782

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00016822

Identifier Type: -

Identifier Source: org_study_id