Heart Health MarkersPhase 2NCT07078344
Omega-3D: Omega-3 for Diet-Driven Health Disparities
A Phase 2 study of Heart Health Markers and Cardiovascular Diseases, run by University of Arizona at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Health Markers, Cardiovascular Diseases, Omega 3 Fatty Acids
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jul 2025to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Arizona Cancer Center
Tucson, Arizona, 85719
Patricia A Thompson, PhD, 520-626-3138, pcarino@arizona.edu
- Not yet recruiting
Georgetown University
Washington D.C., District of Columbia, 20057
About this study
Official title: Addressing Diet-Induced Health Disparities With Precision Nutrition and Omega-3 Fatty Acids
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.
- Being tested
- Omega-3 Fatty Acids and Safflower Oil Placebo, Safflower Oil Placebo and Omega-3 Fatty Acids
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Fatty Acids and Safflower Oil PlaceboDietary supplement
Blinded study supplement; appearance-matched softgels.
Safflower Oil Placebo and Omega-3 Fatty AcidsDietary supplement
Blinded study supplement; appearance-matched softgels.
| Study group | Role | What they receive |
|---|---|---|
| Blinded Crossover Arm: Omega-3 Fatty Acids and Safflower Oil Placebo | Experimental | 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. Receives: Dietary Supplement: Omega-3 Fatty Acids and Safflower Oil Placebo; Dietary Supplement: Safflower Oil Placebo and Omega-3 Fatty Acids |
| Blinded Crossover Arm: Safflower Oil Placebo and Omega-3 Fatty Acids | Experimental | 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. Receives: Dietary Supplement: Omega-3 Fatty Acids and Safflower Oil Placebo; Dietary Supplement: Safflower Oil Placebo and Omega-3 Fatty Acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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
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.
Measured: 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
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.
Measured: From enrollment to end of Phase II treatment (Week 36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start31 Jul 2025
- Primary completion31 May 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Health MarkersStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Georgetown University
- Responsible party
- Principal investigator, Patricia Thompson, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078344
- Sponsor's protocol ID
- STUDY00005456
- Other IDs
- 2R01AT008621-07
- Status last verified
- Dec 2025
- First submitted
- 10 Apr 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Diet-Induced Health Disparities With Precision Nutrition and Omega-3 Fatty Acids
- ClinicalTrials.gov ID
- NCT07078344
- Acronym / sponsor ID
- STUDY00005456
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Georgetown University
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blinded Crossover Arm: Omega-3 Fatty Acids and Safflower Oil Placebo | Experimental | Dietary Supplement: Omega-3 Fatty Acids and Safflower Oil Placebo, Dietary Supplement: Safflower Oil Placebo and Omega-3 Fatty AcidsParticipants 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. |
| Blinded Crossover Arm: Safflower Oil Placebo and Omega-3 Fatty Acids | Experimental | Dietary Supplement: Omega-3 Fatty Acids and Safflower Oil Placebo, Dietary Supplement: Safflower Oil Placebo and Omega-3 Fatty AcidsParticipants 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 Fatty Acids and Safflower Oil PlaceboBlinded study supplement; appearance-matched softgels. | Dietary supplement | Blinded Crossover Arm: Omega-3 Fatty Acids and Safflower Oil Placebo, Blinded Crossover Arm: Safflower Oil Placebo and Omega-3 Fatty Acids |
| Safflower Oil Placebo and Omega-3 Fatty AcidsBlinded study supplement; appearance-matched softgels. | Dietary supplement | Blinded Crossover Arm: Omega-3 Fatty Acids and Safflower Oil Placebo, Blinded Crossover Arm: Safflower Oil Placebo and Omega-3 Fatty Acids |
Primary outcome
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)
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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Heart Health Markers
Not yet recruitingPhase 4
Semaglutide and Structured Lifestyle Support to Improve Heart and Blood Vessel Health in Postmenopausal Obese Breast Cancer Survivors Taking Aromatase Inhibitors
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Recruiting
Does Style Matter: Comparison of Moderate- to Low-intensity Styles of Yoga
Insomnia, Health Adult Subjects
Recruiting
Acute Impact of Whey Protein-enriched Milk Fat Globule Membrane Supplementation on Postprandial Markers of Heart and Brain Health
Cardiovascular Diseases, Cognition
Recruiting
Examination of the Impact of CalmiGo's Stress Management Device on Vascular Heath and Cardiovascular Disease Risk.
Myocardial Infarction
Recruiting
Impact of Training Load on the Gut miCrobiome And Its Relation to exeRcise Performance, mUscle Phenotype, and markerS of Overreaching in Healthy Men
Exercise, Overreaching
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Heart Health Markers and Cardiovascular Diseases, run by University of Arizona at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susana Chavez ((520) 626-2548, schavezabril@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.