[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04916327":3,"trial-entities:NCT04916327":94,"trial-summary:NCT04916327":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":44,"secondary_outcomes":54,"sex":55,"minimum_age":56,"maximum_age":57,"healthy_volunteers":14,"eligibility_criteria":58,"std_ages":72,"locations":74,"central_contacts":83,"overall_officials":89,"references":92,"see_also_links":93},"NCT04916327","HM20020955-1","Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 1","RECRUITING","2026-08","2026-06","2026-07-01","2021-08-23","Virginia Commonwealth University","OTHER",true,"The purpose of this research study is to examine the role oxidants, substances produced in the blood that can damage blood vessel function, may play in blood vessel function in healthy individuals as well as individuals with mental health disorders (posttraumatic stress disorder (PTSD) and\u002For generalized anxiety disorder (GAD)).","Study #1 is made up of three sessions done on three separate days and the entire study can be completed in as little as two weeks. All testing sessions will take place at the Exercise Physiology Research Laboratory. Volunteers will be asked to participate in one initial testing session (Visit 1) lasting \\\u003C 1 hour that will help make them more familiar with the study equipment and procedures, determine body measures (height, weight, body fat), determine the maximum strength of their forearm and calf, and require one blood draw. The following two testing sessions (Visits 2 and 3) with each session lasting between 2-3 hours that will involve multiple tests designed to determine the health of their blood vessels. For Visit #2 they will be randomly given either antioxidant pills or placebo pills to determine the effect of oxidants on blood vessel health. For Visit #3, they will be given whatever set of pills (antioxidant or placebo) that they did not receive during Visit #2.",[18],"Peripheral Vascular Diseases",[20,21,22,23,24],"cardiovascular disease","vascular function","PTSD","GAD","Oxidant","INTERVENTIONAL","BASIC_SCIENCE",[28],"NA",{"count":30,"type":31},720,"ESTIMATED",[33,40],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DIETARY_SUPPLEMENT","Antioxidant","Subjects will ingest an antioxidant cocktail containing 800 milligrams of alpha lipoic acid, 1 gram of vitamin C (ascorbic acid), and 400 milligrams of vitamin E (alpha tocopherol).",[38,39],"Antioxidant then Placebo","Placebo then Antioxidant",{"type":34,"name":41,"description":42,"armGroupLabels":43},"Placebo","Subjects will ingest placebo (microcrystalline cellulose) pills.",[38,39],[45,49,52],{"measure":46,"description":47,"timeFrame":48},"Arm Vascular Function at Rest (Flow Mediated Dilation Test)","Change in Brachial Artery Dilation from Baseline Values","Baseline to the end of the final visit, about 2 weeks",{"measure":50,"description":51,"timeFrame":48},"Leg Vascular Function (Passive Leg Movement Test)","Change in Leg Blood Flow Values from Baseline",{"measure":53,"description":47,"timeFrame":48},"Arm Vascular Function in Response to Exercise (Handgrip Exercise Test)",[],"ALL","18 Years","35 Years",{"inclusion":59,"exclusion":64,"raw_text":71},[60,61,62,63],"apparently healthy and free of overt cardiovascular, pulmonary, or metabolic disease","for PTSD group, a score of ≥ 33 on PCL-5 checklist","for GAD group, a score of ≥ 10 on the GAD-7 self-report scale and \\\u003C 33 on the PCL-5 checklist","for Healthy Control group, a score of ≤ 10 on the GAD-7 self-report scale and \\\u003C 33 on the PCL-5 checklist",[65,66,67,68,69,70],"taking medications that could influence cardiovascular function","current smokers who have recently quit smoking","illicit drug use or excessive alcohol consumption","pregnant women","significant calorie restriction or vitamin\u002Fmineral deficiencies","limited English proficiency","Inclusion Criteria:\n\n* apparently healthy and free of overt cardiovascular, pulmonary, or metabolic disease\n* for PTSD group, a score of ≥ 33 on PCL-5 checklist\n* for GAD group, a score of ≥ 10 on the GAD-7 self-report scale and \\\u003C 33 on the PCL-5 checklist\n* for Healthy Control group, a score of ≤ 10 on the GAD-7 self-report scale and \\\u003C 33 on the PCL-5 checklist\n\nExclusion Criteria:\n\n* taking medications that could influence cardiovascular function\n* current smokers who have recently quit smoking\n* illicit drug use or excessive alcohol consumption\n* pregnant women\n* significant calorie restriction or vitamin\u002Fmineral deficiencies\n* limited English proficiency",[73],"ADULT",[75],{"facility":12,"status":7,"city":76,"state":77,"zip":78,"country":79,"geoPoint":80},"Richmond","Virginia","23298","United States",{"lat":81,"lon":82},37.55376,-77.46026,[84],{"name":85,"role":86,"phone":87,"email":88},"Ryan Garten, PhD","CONTACT","(804) 828-1948","rsgarten@vcu.edu",[90],{"name":85,"affiliation":12,"role":91},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":95,"biomarkers":99},[96,97,98],"Generalized Anxiety Disorder","Peripheral Vascular Disorder","Post-Traumatic Stress Disorder",[],{"nct_id":4,"found":14,"summary":101,"prompt_version":111},{"design":102,"status":103,"heading":104,"summary":105,"follow_up":106,"word_count":107,"commitments":108,"compensation":109,"drugs_mentioned":110},"This is an interventional study where participants will be randomly given either antioxidant pills or placebo pills. The study aims to enroll 720 participants.","completed","Study on Antioxidants and Blood Vessel Function in Mental Health","This study is looking at how substances called oxidants, which can harm blood vessels, affect blood vessel health in people with and without mental health conditions like posttraumatic stress disorder (PTSD) or generalized anxiety disorder (GAD). You could be eligible if you are between 18 and 35 years old and are generally healthy, with or without PTSD or GAD. Participants will receive either an antioxidant cocktail (containing alpha lipoic acid, vitamin C, and vitamin E) or a placebo (inactive pill). Researchers will measure how well your arm and leg blood vessels function at rest and during exercise. The study is currently unclear on its recruitment status and plans to enroll 720 people.","Your blood vessel function will be measured from the beginning of the study until the end of the final visit, which is about two weeks later.",112,"You would have three study visits over about two weeks. The first visit is less than an hour, and the next two visits are 2-3 hours each, involving various blood vessel tests and one blood draw.","Not stated in the trial record.",[35,41],"v2"]