NCT07078344

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

Addressing Diet-Induced Health Disparities With Precision Nutrition and Omega-3 Fatty Acids

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-31
• Primary completion: 2029-05-31
• Completion: 2029-12-31
• First posted: 2025-07-22
• Last updated: 2025-12-16

Locations

2 sites across 1 country: United States