Cardiovascular Diseases, Heart Health Markers, Omega 3 Fatty Acids
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTOmega-3 Fatty Acids and Safflower Oil Placebo
Blinded study supplement; appearance-matched softgels.
DIETARY_SUPPLEMENTSafflower Oil Placebo and Omega-3 Fatty Acids
Blinded study supplement; appearance-matched softgels.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Georgetown University
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Identical capsules and packaging for omega-3 and safflower oil placebo; blinded allocation and crossover order.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in circulating arachidonic acid (ARA) between baseline and the end of each 12-week treatment period | From enrollment to end of phase 2 treatment (week 36) | This outcome evaluates the within-subject change in circulating arachidonic acid. Measurements are collected at baseline and at the end of each 12-week treatment phase in a 36-week randomized, double-blind, placebo-controlled crossover trial. |
| Mean change in the ARA:DGLA ratio between baseline and the end of each 12-week treatment period | From enrollment to the end of Phase II intervention at 32 weeks. | This outcome assesses the within-subject change in the ratio of arachidonic acid (ARA) to dihomo-γ-linolenic acid (DGLA), calculated using molar concentrations, from baseline to the end of each 12-week treatment period. A higher ARA:DGLA ratio reflects greater FADS1 enzymatic activity. Ratios are calculated using plasma phospholipid fatty acid levels measured by mass spectrometry in a 36-week randomized, double-blind, placebo-controlled crossover trial. |
| Mean change in the ARA:EPA ratio between baseline and the end of each 12-week treatment period. | From enrollment to the end of treatment Phase II at 32 weeks. | This outcome assesses the within-subject change in the ratio of arachidonic acid (ARA) to eicosapentaenoic acid (EPA), calculated using molar concentrations, from baseline to the end of each 12-week treatment period. A lower ARA:EPA ratio indicates a shift toward greater omega-3 fatty acid abundance. Ratios are derived from plasma phospholipid fatty acid levels measured by mass spectrometry in a 36-week randomized, double-blind, placebo-controlled crossover trial. |
| Genotype-dependent differences in the effect of omega-3 supplementation on circulating arachidonic acid (ARA) levels. | From enrollment to end of phase 2 treatment (week 36) | This outcome assesses whether the magnitude of change in circulating arachidonic acid (ARA), measured in micrograms per milliliter (µg/mL) of plasma phospholipids, differs by FADS genotype. The analysis compares within-subject treatment effects (omega-3 supplementation vs placebo) across genotype groups (e.g., GG, GT, TT) to evaluate genotype-dependent modification of response. ARA is measured at baseline and at the end of each 12-week treatment period in a 36-week randomized, double-blind, placebo-controlled crossover trial. Genotyping is performed using validated single nucleotide polymorphism (SNP) assays. |
| Genotype-dependent differences in the effect of omega-3 supplementation on the ARA:DGLA ratio | From enrollment to end of Phase II treatment (Week 36) | This outcome assesses whether the magnitude of change in the ratio of arachidonic acid (ARA) to dihomo-γ-linolenic acid (DGLA), calculated using molar concentrations, differs by FADS genotype. The analysis compares within-subject treatment effects across genotype groups (e.g., GG, GT, TT) to evaluate genotype-dependent modification of response. ARA:DGLA ratio is derived from plasma phospholipid fatty acid levels measured at baseline and at the end of each 12-week treatment period in a 36-week randomized, double-blind, placebo-controlled crossover trial. Genotyping is conducted using validated SNP assays. |
| Genotype-dependent differences in the effect of omega-3 supplementation on the ARA:EPA ratio | From enrollment to end of Phase II treatment (Week 36) | This outcome assesses whether the magnitude of change in the ratio of arachidonic acid (ARA) to eicosapentaenoic acid (EPA), calculated using molar concentrations, differs by FADS genotype. The analysis compares within-subject treatment effects across genotype groups (e.g., GG, GT, TT) to evaluate genotype-dependent modification of response. The ARA:EPA ratio is calculated from plasma phospholipid fatty acid levels measured at baseline and at the end of each 12-week treatment period in a 36-week randomized, double-blind, placebo-controlled crossover trial. Genotyping is performed using validated SNP assays. |
Countries
United States
Contacts
Primary ContactSusana Chavez
Backup ContactSusan Schembre, PhD
Outcome results
None listed