Omega-3 supplements to address diet-driven health disparities
Addressing Diet-Induced Health Disparities With Precision Nutrition and Omega-3 Fatty Acids
PHASE2 · University of Arizona · NCT07078344
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
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | University of Arizona (other) |
| Locations | 2 sites (Tucson, Arizona and 1 other locations) |
| Trial ID | NCT07078344 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Tucson, Arizona and 1 other locations
- Arizona Cancer Center — Tucson, Arizona, United States (RECRUITING)
- Georgetown University — Washington D.C., District of Columbia, United States (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Susana Chavez
- Email: schavezabril@arizona.edu
- Phone: (520) 626-2548
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Health Markers, Cardiovascular Diseases, Omega 3 Fatty Acids