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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-64
SponsorUniversity of Arizona

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Age > 65 years

BMI ≥ 40 kg/m2

Currently pregnant or breastfeeding.

Currently receiving treatment for cancer (excluding adjuvant therapies).

Trial design

Treatments tested in this trial

  • Omega-3 Fatty Acids and Safflower Oil Placebo
  • Safflower Oil Placebo and Omega-3 Fatty Acids

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Arizona

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Georgetown University

Collaborator