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Omega-3 Supplementation in Improving Heart Health in Healthy Patients with Different Genetic Backgrounds, Omega-3D Trial
Trial Status: active
This phase I trial studies the impact of omega-3 supplementation on heart health in patients with different genetic backgrounds. Previous studies of the heart-protective effects of omega-3 fatty acids have lacked diversity. Research has shown that genetic differences in a gene cluster called fatty acid desaturase (FADS), affect how fatty acids are processed. African Americans, for instance, often have a less favorable balance, leading to more inflammation and blood clotting issues. Omega-3 fatty acids are essential nutrients that are derived from fish oil and have been shown to be relevant for heart health, inflammation, and other endocrine processes. Information gathered from this trial may help researchers understand the genetic differences that affect how omega-3 supplements impact heart health leading to more personalized dietary advice and better strategies for heart health and reducing the risk of developing chronic illness and/or cancer in diverse populations.
Inclusion Criteria
Age ≥ 18 years
* Self-reported (birthdate)
Body mass index (BMI) ≥ 18.5 kg/m^2
* Computed from self-reported weight and height (confirmed by in-person measures of weight and height)
Self-identify as non-Hispanic African American or non-Hispanic European American
* Self-reported
Ability and willingness to transport for regular clinic visits
* Self-reported
Ability and willingness to swallow study capsules
* Self-reported
Willingness to refrain from intentional weight loss
* Self-reported
Willingness maintain usual physical activity levels and dietary intake throughout the trial
* Self-reported
Exclusion Criteria
Age > 65 years
* Self-reported (birthdate)
BMI ≥ 40 kg/m^2
* Computed from self-reported weight and height (confirmed by in-person measures of weight and height)
Currently pregnant or breastfeeding
* Self-reported
Currently receiving treatment for cancer (excluding adjuvant therapies)
* Self-reported
Consumption of DHA/EPA-rich fish 2 or more days a week (defined as > 0.5 g DHA or EPA/serving)
* Self-reported (usual intake of salmon, mackerel, or herring)
Has a history of atrial fibrillation
* Self-reported (via CHARGE-AF)
Has been diagnosed with a significant psychiatric condition that might compromise adherence to study protocols, including eating disorders, schizophrenia, bipolar (manic phase), severe personality disorders, severe major depressive, severe anxiety disorders, and substance use disorders
* Self-reported
Have an allergy to the study oils
* Self-reported
Have received other investigational agents within the past 6 months
* Self-reported
Currently on a weight reducing diet or has lost > 5% body weight in the past 6 months
* Self-reported (computed from current weight)
Currently using glucagon-like peptide (GLP)-1
* Self-reported (confirmed by medication and supplement log at first in-person visit then monitored via study application [app])
* Note: Individuals who are otherwise eligible may opt for delayed enrollment) until which time they have refrained from using other investigational agents or n-3 or n-3-like supplements for the defined exclusionary period (≥ 2 weeks for aspirin and non-steroidal antiinflammatory drugs [NSAIDs] and ≥ 12 weeks for other exclusionary medications or supplements)
Currently using prescribed anticoagulants or have a blood clotting problem or disease that causes excessive bleeding or been told by a physician that you have an increased risk of serious bleeding
* Self-reported (confirmed by medication and supplement log at first in-person visit then monitored via study app)
* Note: Individuals who are otherwise eligible may opt for delayed enrollment) until which time they have refrained from using other investigational agents or n-3 or n-3-like supplements for the defined exclusionary period (≥ 2 weeks for aspirin and NSAIDs and ≥ 12 weeks for other exclusionary medications or supplements)
Currently using oral steroids
* Self-reported (confirmed by medication and supplement log at first in-person visit then monitored via study app)
* Note: Individuals who are otherwise eligible may opt for delayed enrollment) until which time they have refrained from using other investigational agents or n-3 or n-3-like supplements for the defined exclusionary period (≥ 2 weeks for aspirin and NSAIDs and ≥ 12 weeks for other exclusionary medications or supplements)
Perceivably unable or unwilling to use acetaminophen in place of aspirin (including low dose regimen), NSAIDS, or other cyclooxygenase (COX)-2 inhibitors
* Self-reported (confirmed by medication and supplement log at first in-person visit then monitored via study app)
* Note: Individuals who are otherwise eligible may opt for delayed enrollment) until which time they have refrained from using other investigational agents or n-3 or n-3-like supplements for the defined exclusionary period (≥ 2 weeks for aspirin and NSAIDs and ≥ 12 weeks for other exclusionary medications or supplements)
Perceivably unable or unwilling to refrain from using anti- inflammatory supplements (including n-3 supplements)
Perceivably unable or unwilling to refrain from using montelukast-type of allergy medications
* Defined as (1) taking < 80% of the study pills and (2) non-compliance with discontinued use of exclusionary medications and supplements during the run-in period
Run-in failure
* Self-report inability to take run-in pills as prescribed (< 80 %) and/or continued use of exclusionary medications
Additional locations may be listed on ClinicalTrials.gov for NCT07078344.
I. Eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) supplementation will shift concentrations of n-3 and n-6 highly unsaturated fatty acids (HUFA) and their oxylipin signaling metabolites from pro- to anti-inflammatory and from pro- to anti-thrombotic profiles in African Americans (AfAM) (> European Americans [EuAm]) participants, in an (a)-race and (b)-FADS variation-dependent manner, adjusted for baseline dietary intake.
II. EPA+DHA supplementation will decrease inflammatory biomarkers (interleukin-6 [IL-6], tumor necrosis factor [TNF]- alpha, high sensitivity C-reactive protein [hsCRP]) and improve cardiometabolic (insulin, glucose, serum lipids) risk biomarkers in AfAM (> EuAm) participants in an (a)-race and (b)-FADS variation-dependent manner, adjusted for baseline dietary intake.
OUTLINE:
RUN-IN: Patients receive placebo supplement (safflower oil) orally (PO) three times daily (TID) for 4 weeks. Patients successfully completing the run-in period are randomized to 1 of 2 groups.
GROUP A:
PHASE I: Patients receive omega-3 supplement or safflower oil PO TID for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
WASHOUT: Patients continue usual diet and physical activity for 8 weeks.
PHASE II: Patients receive alternative dietary supplement not received in Phase I (either omega-3 supplement or safflower oil) PO TID for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
GROUP B:
PHASE I: Patients receive safflower oil or omega-3 supplement PO TID for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
WASHOUT: Patients continue usual diet and physical activity for 8 weeks.
PHASE II: Patients receive alternative dietary supplement not received in Phase I (either safflower oil or omega-3 supplement) PO TID for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
Additionally, patients undergo blood sample collection throughout the study.
Trial PhasePhase I
Trial Typeprevention
Lead OrganizationBanner University Medical Center - Tucson
