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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 64 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Basic Science
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Identical capsules and packaging for omega-3 and safflower oil placebo; blinded allocation and crossover order.

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Dietary Supplement: Omega-3 Fatty Acids and Safflower Oil Placebo
    Blinded study supplement; appearance-matched softgels.
  • Dietary Supplement: Safflower Oil Placebo and Omega-3 Fatty Acids
    Blinded study supplement; appearance-matched softgels.
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.
  • Dietary Supplement: Omega-3 Fatty Acids and Safflower Oil Placebo
    Blinded study supplement; appearance-matched softgels.
  • Dietary Supplement: Safflower Oil Placebo and Omega-3 Fatty Acids
    Blinded study supplement; appearance-matched softgels.

Recruiting Locations

Arizona Cancer Center
Tucson 5318313, Arizona 5551752 85719
Contact:
Patricia A Thompson, PhD
520-626-3138
pcarino@arizona.edu

More Details

Status
Recruiting
Sponsor
University of Arizona

Study Contact

Susana Chavez
(520) 626-2548
schavezabril@arizona.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.