NCT07078344 Omega-3D: Omega-3 for Diet-Driven Health Disparities
| NCT ID | NCT07078344 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Arizona |
| Condition | Heart Health Markers |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-07-31 |
| Primary Completion | 2029-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2025-07-31 with a primary completion date of 2029-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn whether omega-3 fatty acid supplementation can reduce inflammation-related biomarkers and improve cardiovascular health in healthy adult volunteers with different genetic backgrounds. The main questions it aims to answer are: Does the response to omega-3 supplementation differ based on genetic variation in the FADS gene cluster (specifically rs174537)? Are changes in fatty acid ratios and inflammation markers greater among individuals of African ancestry compared to those of European ancestry? Researchers will compare omega-3 supplements to a placebo in a randomized, placebo-controlled crossover study to determine whether the Omega-3 supplementation is more effective in certain genetic and ancestry groups. Participants will take omega-3 supplements or a placebo daily for a defined period, then cross over to the other intervention. They will provide blood samples for analysis of fatty acid levels and inflammatory markers, complete questionnaires, and attend scheduled study visits.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * BMI ≥ 18.5 kg/m2 * Self-identify as non-Hispanic African American or non-Hispanic European American * Ability and willingness to transport for regular clinic visits. * Ability and willingness to swallow study capsules. * Willingness to refrain from intentional weight loss * Willingness maintain usual physical activity levels and dietary intake throughout the trial. Exclusion Criteria: * Age \> 65 years * BMI ≥ 40 kg/m2 * Currently pregnant or breastfeeding. * Currently receiving treatment for cancer (excluding adjuvant therapies). * Consumption of DHA/EPA-rich fish 2 or more days a week (defined as \>0.5 g DHA or EPA/serving) * Has a history of atrial fibrillation. * 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. * Have an allergy to the study oils. * Have received other investigational agents within the past 6 months. * Currently on a weight reducing diet or has lost \>5% body weight in the past 6 months. * Currently using GLP-1 * 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 * Currently using oral steroids * Perceivably unable or unwilling to use acetaminophen in place of aspirin (including low dose regimen), NSAIDS, or other COX-2 inhibitors. * 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. * Run-in failure
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07078344 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Heart Health Markers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07078344 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07078344 currently recruiting?
Yes, NCT07078344 is actively recruiting participants. Contact the research team at schavezabril@arizona.edu for enrollment information.
Where is the NCT07078344 trial being conducted?
This trial is being conducted at Tucson, United States, Washington D.C., United States.
Who is sponsoring the NCT07078344 clinical trial?
NCT07078344 is sponsored by University of Arizona. The trial plans to enroll 200 participants.