Omega-3D: Omega-3 for Diet-Driven Health Disparities
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Omega-3 Fatty Acids and Safflower Oil Placebo, Safflower Oil Placebo and Omega-3 Fatty Acids.
- Who it may be relevant to
- Registry conditions: Heart Health Markers, Cardiovascular Diseases, Omega 3 Fatty Acids. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Addressing Diet-Induced Health Disparities With Precision Nutrition and Omega-3 Fatty Acids
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Basic science
Study locations
United States · 2 centers
- Arizona Cancer Center — Tucson
- Georgetown University — Washington D.C.
Identifiers
NCT: NCT07078344 · STUDY00005456 · 2R01AT008621-07