Actively Recruiting
Omega-3D: Omega-3 for Diet-Driven Health Disparities
Led by University of Arizona · Updated on 2025-12-16
200
Participants Needed
2
Research Sites
230 weeks
Total Duration
On this page
Sponsors
U
University of Arizona
Lead Sponsor
N
National Center for Complementary and Integrative Health (NCCIH)
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Omega-3D: Omega-3 for Diet-Driven Health Disparities
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Body mass index (BMI) of 18.5 kg/m2 or higher
- Self-identify as non-Hispanic African American or non-Hispanic European American
- Ability and willingness to travel for regular clinic visits
- Ability and willingness to swallow study capsules
- Willingness to avoid intentional weight loss during the study
- Willingness to maintain usual physical activity and diet throughout the trial
You will not qualify if you...
- Age over 65 years
- Body mass index (BMI) of 40 kg/m2 or higher
- Currently pregnant or breastfeeding
- Receiving treatment for cancer (except maintenance or adjuvant therapies)
- Eating DHA/EPA-rich fish two or more days per week (more than 0.5 g DHA or EPA per serving)
- History of atrial fibrillation
- Diagnosed with serious psychiatric conditions that might affect study adherence, including eating disorders, schizophrenia, bipolar disorder (manic phase), severe personality disorders, severe major depression, severe anxiety, or substance use disorders
- Allergy to the study oils
- Used other investigational agents within the past 6 months
- Currently on a weight loss diet or lost more than 5% body weight in the past 6 months
- Currently using GLP-1 medications
- Using prescribed blood thinners, have bleeding disorders, or advised by a doctor about high bleeding risk
- Using oral steroids
- Unable or unwilling to use acetaminophen instead of aspirin, NSAIDs, or COX-2 inhibitors
- Unable or unwilling to avoid anti-inflammatory supplements including omega-3 supplements
- Unable or unwilling to avoid montelukast-type allergy medications
- Failed the study run-in period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Arizona Cancer Center
Tucson, Arizona, United States, 85719
Actively Recruiting
2
Georgetown University
Washington D.C., District of Columbia, United States, 20057
Not Yet Recruiting
Research Team
S
Susana Chavez
CONTACT
S
Susan Schembre, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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