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
This trial accepts healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Omega-3 Fatty Acids and Safflower Oil Placebo
Dietary supplementBlinded study supplement; appearance-matched softgels.
Safflower Oil Placebo and Omega-3 Fatty Acids
Dietary supplementBlinded study supplement; appearance-matched softgels.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Blinded Crossover Arm: Omega-3 Fatty Acids and Safflower Oil PlaceboExperimental treatment 2 interventions
Group B: Blinded Crossover Arm: Safflower Oil Placebo and Omega-3 Fatty AcidsExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Mean change in circulating arachidonic acid (ARA) between baseline and the end of each 12-week treatment period
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.
Time frame
From enrollment to end of phase 2 treatment (week 36)2
Mean change in the ARA:DGLA ratio between baseline and the end of each 12-week treatment period
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.
Time frame
From enrollment to the end of Phase II intervention at 32 weeks.3
Mean change in the ARA:EPA ratio between baseline and the end of each 12-week treatment period.
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.
Time frame
From enrollment to the end of treatment Phase II at 32 weeks.4
Genotype-dependent differences in the effect of omega-3 supplementation on circulating arachidonic acid (ARA) levels.
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.
Time frame
From enrollment to end of phase 2 treatment (week 36)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Arizona
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Georgetown University
Collaborator
Source ClinicalTrials.gov