Recruiting
Phase 2

Omega-3

Sponsor:

University of Arizona

Code:

NCT07078344

Conditions

Heart Health Markers

Cardiovascular Diseases

Omega 3 Fatty Acids

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

Interventions

Omega-3 Fatty Acids and Safflower Oil Placebo

Safflower Oil Placebo and Omega-3 Fatty Acids

Study Details

Brief summary:

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

Heart Health Markers

Cardiovascular Diseases

Omega 3 Fatty Acids

Study ID

NCT07078344

Start date

Jul 31, 2025

Status verified date

Dec, 2025

Completion date

Dec 31, 2029

Anticipated

Primary completion date

May 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

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

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Omega-3 Fatty Acids and Safflower Oil Placebo

Blinded study supplement; appearance-matched softgels.

Safflower Oil Placebo and Omega-3 Fatty Acids

Blinded study supplement; appearance-matched softgels.

Primary outcome measure

  • Mean change in circulating arachidonic acid (ARA) between baseline and the end of each 12-week treatment period [ Time Frame: From enrollment to end of phase 2 treatment (week 36) ]
  • Mean change in the ARA:DGLA ratio between baseline and the end of each 12-week treatment period [ Time Frame: From enrollment to the end of Phase II intervention at 32 weeks. ]
  • Mean change in the ARA:EPA ratio between baseline and the end of each 12-week treatment period. [ Time Frame: From enrollment to the end of treatment Phase II at 32 weeks. ]
  • Genotype-dependent differences in the effect of omega-3 supplementation on circulating arachidonic acid (ARA) levels. [ Time Frame: From enrollment to end of phase 2 treatment (week 36) ]
  • Genotype-dependent differences in the effect of omega-3 supplementation on the ARA:DGLA ratio [ Time Frame: From enrollment to end of Phase II treatment (Week 36) ]
  • Genotype-dependent differences in the effect of omega-3 supplementation on the ARA:EPA ratio [ Time Frame: From enrollment to end of Phase II treatment (Week 36) ]

Central Contacts and Locations

Central contacts

Susana Chavez

(520) 626-2548schavezabril@arizona.edu

Susan Schembre, PhD

2026870802ss4731@georgetown.edu

Locations

Arizona Cancer Center

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Patricia A Thompson, PhD

520-626-3138pcarino@arizona.edu

More Information

Sponsor

University of Arizona

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by University of Arizona on 2025-12-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.