[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07078344":3,"trial-entities:NCT07078344":135,"trial-summary:NCT07078344":139},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":41,"secondary_outcomes":64,"sex":65,"minimum_age":66,"maximum_age":67,"healthy_volunteers":15,"eligibility_criteria":68,"std_ages":96,"locations":98,"central_contacts":123,"overall_officials":132,"references":133,"see_also_links":134},"NCT07078344","STUDY00005456","Omega-3D: Omega-3 for Diet-Driven Health Disparities","Addressing Diet-Induced Health Disparities With Precision Nutrition and Omega-3 Fatty Acids","RECRUITING","2029-12-31","2025-12","2025-12-16","2025-07-31","University of Arizona","OTHER",true,"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.",null,[19,20,21],"Heart Health Markers","Cardiovascular Diseases","Omega 3 Fatty Acids",[],"INTERVENTIONAL","BASIC_SCIENCE",[26],"PHASE2",{"count":28,"type":29},200,"ESTIMATED",[31,38],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DIETARY_SUPPLEMENT","Omega-3 Fatty Acids and Safflower Oil Placebo","Blinded study supplement; appearance-matched softgels.",[36,37],"Blinded Crossover Arm: Omega-3 Fatty Acids and Safflower Oil Placebo","Blinded Crossover Arm: Safflower Oil Placebo and Omega-3 Fatty Acids",{"type":32,"name":39,"description":34,"armGroupLabels":40},"Safflower Oil Placebo and Omega-3 Fatty Acids",[36,37],[42,46,50,54,57,61],{"measure":43,"description":44,"timeFrame":45},"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.","From enrollment to end of phase 2 treatment (week 36)",{"measure":47,"description":48,"timeFrame":49},"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.","From enrollment to the end of Phase II intervention at 32 weeks.",{"measure":51,"description":52,"timeFrame":53},"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.","From enrollment to the end of treatment Phase II at 32 weeks.",{"measure":55,"description":56,"timeFrame":45},"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\u002FmL) 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.",{"measure":58,"description":59,"timeFrame":60},"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.","From enrollment to end of Phase II treatment (Week 36)",{"measure":62,"description":63,"timeFrame":60},"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.",[],"ALL","18 Years","64 Years",{"inclusion":69,"exclusion":77,"raw_text":95},[70,71,72,73,74,75,76],"Age ≥ 18 years","BMI ≥ 18.5 kg\u002Fm2","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.",[78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94],"Age \\> 65 years","BMI ≥ 40 kg\u002Fm2","Currently pregnant or breastfeeding.","Currently receiving treatment for cancer (excluding adjuvant therapies).","Consumption of DHA\u002FEPA-rich fish 2 or more days a week (defined as \\>0.5 g DHA or EPA\u002Fserving)","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","Inclusion Criteria:\n\n* Age ≥ 18 years\n* BMI ≥ 18.5 kg\u002Fm2\n* Self-identify as non-Hispanic African American or non-Hispanic European American\n* Ability and willingness to transport for regular clinic visits.\n* Ability and willingness to swallow study capsules.\n* Willingness to refrain from intentional weight loss\n* Willingness maintain usual physical activity levels and dietary intake throughout the trial.\n\nExclusion Criteria:\n\n* Age \\> 65 years\n* BMI ≥ 40 kg\u002Fm2\n* Currently pregnant or breastfeeding.\n* Currently receiving treatment for cancer (excluding adjuvant therapies).\n* Consumption of DHA\u002FEPA-rich fish 2 or more days a week (defined as \\>0.5 g DHA or EPA\u002Fserving)\n* Has a history of atrial fibrillation.\n* 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.\n* Have an allergy to the study oils.\n* Have received other investigational agents within the past 6 months.\n* Currently on a weight reducing diet or has lost \\>5% body weight in the past 6 months.\n* Currently using GLP-1\n* 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\n* Currently using oral steroids\n* Perceivably unable or unwilling to use acetaminophen in place of aspirin (including low dose regimen), NSAIDS, or other COX-2 inhibitors.\n* Perceivably unable or unwilling to refrain from using anti- inflammatory supplements (including n-3 supplements).\n* Perceivably unable or unwilling to refrain from using montelukast-type of allergy medications.\n* Run-in failure",[97],"ADULT",[99,114],{"facility":100,"status":8,"city":101,"state":102,"zip":103,"country":104,"contacts":105,"geoPoint":111},"Arizona Cancer Center","Tucson","Arizona","85719","United States",[106],{"name":107,"role":108,"phone":109,"email":110},"Patricia A Thompson, PhD","CONTACT","520-626-3138","pcarino@arizona.edu",{"lat":112,"lon":113},32.22174,-110.92648,{"facility":115,"status":116,"city":117,"state":118,"zip":119,"country":104,"geoPoint":120},"Georgetown University","NOT_YET_RECRUITING","Washington D.C.","District of Columbia","20057",{"lat":121,"lon":122},38.89511,-77.03637,[124,128],{"name":125,"role":108,"phone":126,"email":127},"Susana Chavez","(520) 626-2548","schavezabril@arizona.edu",{"name":129,"role":108,"phone":130,"email":131},"Susan Schembre, PhD","2026870802","ss4731@georgetown.edu",[],[],[],{"nct_id":4,"conditions":136,"biomarkers":138},[137],"Healthy Volunteers",[],{"nct_id":4,"found":15,"summary":140,"prompt_version":150},{"design":141,"status":142,"heading":143,"summary":144,"follow_up":145,"word_count":146,"commitments":147,"compensation":148,"drugs_mentioned":149},"This is an interventional study comparing Omega-3 Fatty Acids to a Safflower Oil Placebo in a randomized, placebo-controlled crossover design, aiming to enroll 200 participants.","completed","Omega-3 Fatty Acids for Heart Health Disparities","This study, called Omega-3D, is looking at whether omega-3 fatty acid supplements can help improve heart health and reduce inflammation in healthy adults. Researchers want to see if the effects of omega-3s are different for people with various genetic backgrounds, specifically comparing individuals of African and European ancestry. You might be able to join if you are between 18 and 64 years old, have a BMI of 18.5 or higher, and identify as non-Hispanic African American or non-Hispanic European American. The study will measure changes in certain fatty acids (like arachidonic acid or ARA) and their ratios to see if the supplements are working. The current recruitment status for this study is unclear.","Participants will be followed from enrollment to the end of the second treatment phase, which is 32 weeks.",113,"You would need to attend regular clinic visits, be willing to swallow study capsules, and maintain your usual physical activity and diet. The treatment periods last 12 weeks each.","Not stated in the trial record.",[],"v2"]