Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2025-07-31
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
64 Years
ALL
Yes
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Georgetown University
OTHER
University of Arizona
OTHER
Responsible Party
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Patricia Thompson
Professor of Physiology
Locations
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Arizona Cancer Center
Tucson, Arizona, United States
Georgetown University
Washington D.C., District of Columbia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00005456
Identifier Type: -
Identifier Source: org_study_id