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Omega-3D: Omega-3 for Diet-Driven Health Disparities

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Phase: Phase 1 to Phase 2
    • Trial status: Active, Not Recruiting to Recruiting
    • Interventions: Omega-3 Fatty Acids (Dietary Supplement), Placebo (Other) to Omega-3 Fatty Acids and Safflower Oil Placebo (Dietary Supplement), Safflower Oil Placebo and Omega-3 Fatty Acids (Dietary Supplement)
    • Study sites revised (2)
    v4
  2. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Start date changed from estimate of Aug 4, 2025 to Jul 31, 2025
    v3
  3. Re-verified, no change to tracked fieldsv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07078344
Lead Sponsor University of Arizona
Collaborators: National Center for Complementary and Integrative Health (NCCIH), Georgetown University
Conditions
(from sponsor)		 Heart Health Markers, Cardiovascular Diseases, Omega 3 Fatty Acids
Related terms Cardiovascular Diseases
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov