[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07644806":3,"trial-entities:NCT07644806":101,"trial-summary:NCT07644806":105},{"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":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":35,"secondary_outcomes":44,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":15,"eligibility_criteria":55,"std_ages":69,"locations":72,"central_contacts":92,"overall_officials":95,"references":99,"see_also_links":100},"NCT07644806","26-01-FB-0005","Olive Oil Supplementation for Heart Failure With Reduced Ejection Fraction","Olive Oil Supplementation to Enhance Exercise Tolerance in Cardiac Rehabilitation in Patients With Heart Failure With Reduced Ejection Fraction: The OLEA-HF Study","NOT_YET_RECRUITING","2028-03-31","2026-06","2026-06-12","2026-07-01","Old Dominion University","OTHER",false,"The OLEA-HF study aims to explore whether daily supplementation of extra-virgin olive oil (EVOO) for 12 weeks during participation in a cardiac rehabilitation program (standard of care) is feasible in patients with heart failure with reduced ejection fraction (HFrEF). The investigators will also determine the effects of EVOO on functional capacity and quality of life.",null,[19],"Heart Failure With Reduced Ejection Fraction (HFrEF)",[21,22],"Cardiomyopathy","Dietary fat quality","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},40,"ESTIMATED",[31],{"type":14,"name":32,"description":33,"armGroupLabels":34},"Extra-virgin olive oil","At least 4 tablespoons of extra-virgin olive oil per day",[32],[36,40],{"measure":37,"description":38,"timeFrame":39},"Change in 24-hour dietary recall monounsaturated fatty acids (MUFA)","Measured with validated 24-hour dietary recall (non-self administered)","At baseline, and 12-week",{"measure":41,"description":42,"timeFrame":43},"Change in dietary compliance (plasma monounsaturated fatty acids)","Measured by changes in biomarkers of monounsaturated fatty acids (MUFA) consumption. Plasma concentrations of MUFA reflect the consumption of a diet rich in MUFA fatty acids, such as oleic acid found in extra-virgin olive oil, making them reliable biomarkers of dietary adherence.","At baseline and 12-week",[45,48],{"measure":46,"timeFrame":47},"6-minute walk test distance","Baseline, 12-week",{"measure":49,"description":50,"timeFrame":51},"Change in quality of life (Kansas City Cardiomyopathy Questionnaire)","The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a self-administered instrument used to evaluate the quality of life of patients with heart failure. The score ranges from 0 to 100. Higher scores indicate fewer symptoms and a better clinical outcome (better quality of life). Change is calculated by subtracting the baseline score from the 12-week score.","Baseline and 12-week","ALL","18 Years","85 Years",{"inclusion":56,"exclusion":60,"raw_text":68},[57,58,59],"Diagnosed with HFrEF with left ventricular ejection fraction ≤35 %.","Referred to and enrolled in the standard cardiac rehabilitation program at Sentara Cardiac Rehabilitation Center, but has not yet initiated\u002Fstarted cardiac rehabilitation (i.e., has not attended the first cardiac rehab session).","Able and willing to comply with study procedures and provide informed consent.",[61,62,63,64,65,66,67],"Co-morbidity expected to limit survival (e.g., terminal illness).","End-stage renal disease.","Unstable fluid overload.","Current pregnancy (self-disclose).","Habitual use of EVOO greater than 4 tablespoons per day.","Known allergy or sensitivity to olive oil or its components.","Unwillingness or inability to incorporate EVOO or dietary recommendations.","Inclusion Criteria:\n\n* Diagnosed with HFrEF with left ventricular ejection fraction ≤35 %.\n* Referred to and enrolled in the standard cardiac rehabilitation program at Sentara Cardiac Rehabilitation Center, but has not yet initiated\u002Fstarted cardiac rehabilitation (i.e., has not attended the first cardiac rehab session).\n* Able and willing to comply with study procedures and provide informed consent.\n\nExclusion Criteria:\n\n* Co-morbidity expected to limit survival (e.g., terminal illness).\n* End-stage renal disease.\n* Unstable fluid overload.\n* Current pregnancy (self-disclose).\n* Habitual use of EVOO greater than 4 tablespoons per day.\n* Known allergy or sensitivity to olive oil or its components.\n* Unwillingness or inability to incorporate EVOO or dietary recommendations.",[70,71],"ADULT","OLDER_ADULT",[73],{"facility":74,"city":75,"state":76,"zip":77,"country":78,"contacts":79,"geoPoint":89},"Strelitz Diabetes Center (Williams Hall)","Norfolk","Virginia","23510","United States",[80,85],{"name":81,"role":82,"phone":83,"email":84},"Salvatore Carbone, PhD, RDN","CONTACT","7574467149","scarbone@odu.edu",{"name":86,"role":82,"phone":87,"email":88},"Saiful Anuar Bin Singar, PhD","757-446-7149","ssingar@odu.edu",{"lat":90,"lon":91},36.84681,-76.28522,[93,94],{"name":81,"role":82,"phone":87,"email":84},{"name":86,"role":82,"phone":87,"email":88},[96],{"name":81,"affiliation":97,"role":98},"Macon & Joan Brock Virginia Health Sciences at Old Dominion University","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":102,"biomarkers":104},[103],"Heart failure with reduced ejection fraction",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]