Role of Polyunsaturated Fatty Acids (PUFA)-Gene Interactions in Heath Disparities
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|ClinicalTrials.gov Identifier: NCT02962128|
Recruitment Status : Recruiting
First Posted : November 11, 2016
Last Update Posted : November 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Fatty Acid-Gene Interactions||Dietary Supplement: High Linoleic Acid (LA) Diet Dietary Supplement: Low Linoleic Acid (LA) Diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Role of PUFA-Gene Interactions in Health Disparities|
|Actual Study Start Date :||November 29, 2016|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2021|
Experimental: High Linoleic Acid (LA) Diet
European Americans (genotypes: TT, GT & GG) and African Americans (genotypes: GT & GG) at rs173537will be randomly assigned to a high LA diet (10% energy) based on a randomized block design with 5 strata defined by race and genotype combinations.
Dietary Supplement: High Linoleic Acid (LA) Diet
Volunteers will be randomly assigned to consumption of a high [10% energy] LA-containing diet for 12 weeks.
Experimental: Low Linoleic Acid (LA) Diet
European Americans (genotypes: TT, GT & GG) and African Americans (genotypes: GT & GG) at rs173537will be randomly assigned to a low LA diet (2.5% energy) based on a randomized block design with 5 strata defined by race and genotype combinations.
Dietary Supplement: Low Linoleic Acid (LA) Diet
Volunteers will be randomly assigned to consumption of a low [2.5% energy] LA-containing diet for 12 weeks.
- Measurement in Change of PUFAs [ Time Frame: 12 Weeks for Each Volunteer ]The primary outcome is the measurement of the change in PUFAs at 12 weeks. Biological specimens (urine and blood) will be collected from each subject at the beginning of the dietary intervention and at 4 week intervals. The primary outcome will be the measured difference between baseline and final PUFA levels before and after the diet.
- Measurement of Change in Serum Lipids (Cholesterol and Triglycerides) [ Time Frame: 12 Weeks for Each Volunteer ]Secondary outcomes will be quantified in mg/dL and assessed using standard methods in an accredited clinical laboratory.
- Measurement of Change in Inflammatory Biomarkers (including Cytokines) [ Time Frame: 12 Weeks for Each Volunteer ]The biochemical endpoints will be measured using established protocols
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02962128
|Contact: Tammy L Mustin, MSfirstname.lastname@example.org|
|Contact: Priscilla Ivester, MS||336-716-7388||Ivester@wakehealth.edu|
|United States, North Carolina|
|Wake Forest Baptist Medical Center||Recruiting|
|Winston-Salem, North Carolina, United States, 27103|
|Contact: Priscilla Ivester 336-716-7388|
|Contact: Tammy Mustin 336-716-7388|
|Principal Investigator:||Susan Sergeant, PhD||Wake Forest University Health Sciences|