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Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 64

Omega-3 supplements to address diet-driven health disparities

Official title: Addressing Diet-Induced Health Disparities With Precision Nutrition and Omega-3 Fatty Acids

Run by University of Arizona · NCT07078344 · Data updated 2026-11-12

This test will see if daily omega-3 supplements lower inflammation and improve heart-related blood markers in healthy non-Hispanic Black and White adults with different FADS gene types.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 64 Years
SexAll
Enrollment200 (estimated)
SponsorUniversity of Arizona
Academic / other
Locations2 sites (Tucson, Arizona and 1 other locations)
StatusRecruiting
StartedJuly 31, 2025
Main results expectedMay 31, 2029
Study endsDecember 31, 2029
Registry record updatedDecember 16, 2025
Trial IDNCT07078344 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are healthy adults aged 18–65 with BMI ≥18.5 and <40 who self-identify as non-Hispanic African American or non-Hispanic European American, can attend clinic visits, avoid high fish intake, and can swallow capsules.

Probably not a fit

People over 65, pregnant or breastfeeding individuals, those currently treated for cancer, people with atrial fibrillation or certain severe psychiatric disorders, and those who regularly eat DHA/EPA-rich fish are unlikely to benefit from participating.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Healthy adults who self-identify as non-Hispanic African American or non-Hispanic European American and meet age and BMI criteria are randomized to receive daily omega-3 capsules or a safflower oil placebo and then cross over to the other treatment after a washout period. Researchers genotype participants for the FADS gene cluster (rs174537) and collect blood samples to measure fatty acid ratios and inflammation biomarkers before and after each intervention period. The randomized, placebo-controlled crossover design allows within-person comparisons to determine whether genetic variation or ancestry predicts a stronger response to omega-3 supplementation. Primary outcomes include changes in blood DHA/EPA levels, fatty acid desaturation ratios, and inflammation markers.

Why it matters

Potential benefit: If successful, the results could help personalize omega-3 recommendations to reduce inflammation and improve cardiovascular risk markers for people with certain genetic backgrounds.

How similar studies have gone: Previous trials have shown that omega-3s can lower some inflammation markers in broad populations, but effects by FADS genetics and by ancestry are less well established and remain mixed.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Arizona Cancer Center
    Tucson, Arizona, United States     Recruiting
  • Georgetown University
    Washington D.C., District of Columbia, United States     Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Heart Health Markers 2Cardiovascular Diseases 365Omega 3 Fatty Acids 3University of Arizona 783
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.