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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Arizona
Study ID
NCT07078344
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cardiovascular Diseases
  • Heart Health Markers
  • Omega 3 Fatty Acids

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • Omega-3 Fatty Acids and Safflower Oil Placebo — DIETARY_SUPPLEMENT
    Blinded study supplement; appearance-matched softgels.
  • Safflower Oil Placebo and Omega-3 Fatty Acids — DIETARY_SUPPLEMENT
    Blinded study supplement; appearance-matched softgels.

Study Details

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.

Key Dates

Start date
Jul 31, 2025
Status verified
Dec 2025
Primary completion
May 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Blinded Crossover Arm: Omega-3 Fatty Acids and Safflower Oil Placebo
    Participants receive both study interventions (omega-3 fatty acid supplement and safflower oil placebo) across two blinded treatment periods in a randomized crossover design. The randomization schedule determines which supplement is administered first, but participants and investigators remain blinded to the identity and order of study supplements.
  • Experimental: Blinded Crossover Arm: Safflower Oil Placebo and Omega-3 Fatty Acids
    Participants receive both study interventions (safflower oil placebo and omega-3 fatty acid supplement) across two blinded treatment periods in a randomized crossover design. The sequence is the opposite of Arm 1, but study blinding prevents participants and investigators from knowing which supplement is administered during each period.

Primary Outcome Measure

Mean change in circulating arachidonic acid (ARA) between baseline and the end of each 12-week treatment period [ Time Frame: From enrollment to end of phase 2 treatment (week 36) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Arizona Cancer CenterTucsonArizona85719
Patricia A Thompson, PhD
[email protected]
520-626-3138
Georgetown UniversityWashington D.C.District of Columbia20057-

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By research site
Arizona Cancer Center· Tucson, AZGeorgetown University· Washington D.C., DC

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