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Omega-3 Fatty Acids for Heart Health Disparities

This study, called Omega-3D, is looking at whether omega-3 fatty acid supplements can help improve heart health and reduce inflammation in healthy adults. Researchers want to see if the effects of omega-3s are different for people with various genetic backgrounds, specifically comparing individuals of African and European ancestry. You might be able to join if you are between 18 and 64 years old, have a BMI of 18.5 or higher, and identify as non-Hispanic African American or non-Hispanic European American. The study will measure changes in certain fatty acids (like arachidonic acid or ARA) and their ratios to see if the supplements are working. The current recruitment status for this study is unclear.

Study design
This is an interventional study comparing Omega-3 Fatty Acids to a Safflower Oil Placebo in a randomized, placebo-controlled crossover design, aiming to enroll 200 participants.
What's involved
You would need to attend regular clinic visits, be willing to swallow study capsules, and maintain your usual physical activity and diet. The treatment periods last 12 weeks each.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from enrollment to the end of the second treatment phase, which is 32 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07078344

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

Recruiting
PHASE2Ages 18–64InterventionalBasic science
University of Arizona
~200 participants
Updated 2025-12-16 on ClinicalTrials.gov
What's tested:Omega-3 Fatty Acids and Safflower Oil PlaceboSafflower Oil Placebo and Omega-3 Fatty Acids

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean change in circulating arachidonic acid (ARA) between baseline and the end of each 12-week treatment period
Measured over From enrollment to end of phase 2 treatment (week 36)
+5 more outcomes measured

Conditions

Heart Health Markers
Cardiovascular Diseases
Omega 3 Fatty Acids

Explore related trials

Healthy Volunteers

NCT07078344

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Arizona Cancer Center

    Tucson, Arizonastudy coordinator listed

    Recruiting

  • Georgetown University

    Washington D.C., District of Columbiano site contact published

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Susana Chavez
[email protected]
(520) 626-2548
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Mean change in circulating arachidonic acid (ARA) between baseline and the end of each 12-week treatment periodFrom enrollment to end of phase 2 treatment (week 36)

    This outcome evaluates the within-subject change in circulating arachidonic acid. Measurements are collected at baseline and at the end of each 12-week treatment phase in a 36-week randomized, double-blind, placebo-controlled crossover trial.

  • Mean change in the ARA:DGLA ratio between baseline and the end of each 12-week treatment periodFrom enrollment to the end of Phase II intervention at 32 weeks.

    This outcome assesses the within-subject change in the ratio of arachidonic acid (ARA) to dihomo-γ-linolenic acid (DGLA), calculated using molar concentrations, from baseline to the end of each 12-week treatment period. A higher ARA:DGLA ratio reflects greater FADS1 enzymatic activity. Ratios are calculated using plasma phospholipid fatty acid levels measured by mass spectrometry in a 36-week randomized, double-blind, placebo-controlled crossover trial.

  • Mean change in the ARA:EPA ratio between baseline and the end of each 12-week treatment period.From enrollment to the end of treatment Phase II at 32 weeks.

    This outcome assesses the within-subject change in the ratio of arachidonic acid (ARA) to eicosapentaenoic acid (EPA), calculated using molar concentrations, from baseline to the end of each 12-week treatment period. A lower ARA:EPA ratio indicates a shift toward greater omega-3 fatty acid abundance. Ratios are derived from plasma phospholipid fatty acid levels measured by mass spectrometry in a 36-week randomized, double-blind, placebo-controlled crossover trial.

  • Genotype-dependent differences in the effect of omega-3 supplementation on circulating arachidonic acid (ARA) levels.From enrollment to end of phase 2 treatment (week 36)

    This outcome assesses whether the magnitude of change in circulating arachidonic acid (ARA), measured in micrograms per milliliter (µg/mL) of plasma phospholipids, differs by FADS genotype. The analysis compares within-subject treatment effects (omega-3 supplementation vs placebo) across genotype groups (e.g., GG, GT, TT) to evaluate genotype-dependent modification of response. ARA is measured at baseline and at the end of each 12-week treatment period in a 36-week randomized, double-blind, placebo-controlled crossover trial. Genotyping is performed using validated single nucleotide polymorphism (SNP) assays.

  • Genotype-dependent differences in the effect of omega-3 supplementation on the ARA:DGLA ratioFrom enrollment to end of Phase II treatment (Week 36)

    This outcome assesses whether the magnitude of change in the ratio of arachidonic acid (ARA) to dihomo-γ-linolenic acid (DGLA), calculated using molar concentrations, differs by FADS genotype. The analysis compares within-subject treatment effects across genotype groups (e.g., GG, GT, TT) to evaluate genotype-dependent modification of response. ARA:DGLA ratio is derived from plasma phospholipid fatty acid levels measured at baseline and at the end of each 12-week treatment period in a 36-week randomized, double-blind, placebo-controlled crossover trial. Genotyping is conducted using validated SNP assays.

  • Genotype-dependent differences in the effect of omega-3 supplementation on the ARA:EPA ratioFrom enrollment to end of Phase II treatment (Week 36)

    This outcome assesses whether the magnitude of change in the ratio of arachidonic acid (ARA) to eicosapentaenoic acid (EPA), calculated using molar concentrations, differs by FADS genotype. The analysis compares within-subject treatment effects across genotype groups (e.g., GG, GT, TT) to evaluate genotype-dependent modification of response. The ARA:EPA ratio is calculated from plasma phospholipid fatty acid levels measured at baseline and at the end of each 12-week treatment period in a 36-week randomized, double-blind, placebo-controlled crossover trial. Genotyping is performed using validated SNP assays.