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

University of Arizona

Status and phase: Enrolling; Phase 2

Conditions: Cardiovascular Diseases; Heart Health Markers; Omega 3 Fatty Acids

Treatments: Dietary Supplement: Omega-3 Fatty Acids and Safflower Oil Placebo; Dietary Supplement: Safflower Oil Placebo and Omega-3 Fatty Acids

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07078344

2R01AT008621-07 (U.S. NIH Grant/Contract)

STUDY00005456

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

Blinded Crossover Arm: Omega-3 Fatty Acids and Safflower Oil Placebo

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Safflower Oil Placebo and Omega-3 Fatty Acids

Dietary Supplement: Omega-3 Fatty Acids and Safflower Oil Placebo

Blinded Crossover Arm: Safflower Oil Placebo and Omega-3 Fatty Acids

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Safflower Oil Placebo and Omega-3 Fatty Acids

Dietary Supplement: Omega-3 Fatty Acids and Safflower Oil Placebo