Screening of Healthy Adults for Genetic Variations That Control Fatty Acid Processing (No)
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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. 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 botanical oil supplements on lipid metabolism and inflammatory biomarkers and 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).
| 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 |
- Determine the genotype at the rs174537 single-nucleotide polymorphism (SNP) in the fatty acid desaturate (FADS) gene cluster [ Time Frame: up to 52 months ] [ Designated as safety issue: No ]
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: | August 2015 |
| Estimated Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| No treatment or intervention |
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Caucasian or African American adults between 21 and 65 years of age
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
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
- Pregnancy
Contacts and Locations| Contact: Priscilla Ivester, M.A. | 336-716-7388 | ivester@wakehealth.edu |
| Contact: Tammy C Lee, M.S. | 336-716-7388 | talee@wakehealth.edu |
| 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. | |
| Principal Investigator: | Floyd (Ski) H Chilton, Ph.D. | Wake Forest University Heath Sciences |
More Information
No publications provided
| Responsible Party: | Floyd H. Chilton, Director of 'The Center for Botanical Lipids and Inflammatory Disease Prevention', Wake Forest University Baptist Medical Center |
| ClinicalTrials.gov Identifier: | NCT01516125 History of Changes |
| Other Study ID Numbers: | NCT, P50AT002782 |
| Study First Received: | January 11, 2012 |
| Last Updated: | January 18, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Wake Forest University Baptist Medical Center:
|
healthy adult genetic variation botanical oils polyunsaturated fatty acid |
fish oil fat metabolism Genetic variation of fat metabolism in healthy adults |
ClinicalTrials.gov processed this record on May 16, 2013