[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07028255":3,"trial-entities:NCT07028255":86,"trial-summary:NCT07028255":90},{"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":40,"secondary_outcomes":45,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":62,"locations":65,"central_contacts":80,"overall_officials":83,"references":84,"see_also_links":85},"NCT07028255","QLS-013","Effectiveness of Qualia Testosterone Supplementation on Testosterone Levels","Effectiveness of Qualia Testosterone Supplementation on Testosterone Levels: A Randomized Double-Blind Parallel Trial","NOT_YET_RECRUITING","2025-10-01","2025-06","2025-06-19","2025-07-01","Qualia Life Sciences","INDUSTRY",false,"This is a randomized, double-blind, placebo-controlled parallel trial designed to assess the efficacy of Qualia Testosterone, a novel dietary supplement, in adult males aged 28 to 65 experiencing symptoms associated with testosterone deficiency. Approximately 60 participants will be randomized to receive either Qualia Testosterone (2 capsules daily) or a matched placebo for 21 days, with dosing administered each morning. The study's primary outcomes are changes in total testosterone, free testosterone (via dialysis), and dihydrotestosterone levels from baseline to Week 3. Secondary outcomes include changes in Aging Male Symptoms Scale scores-encompassing psychological, somatic, and sexual domains-as well as safety and tolerability. Blood samples will be collected in a laboratory setting, while symptom and safety assessments will be completed electronically at home.",null,[19],"Testosterone",[21,22],"testosterone supplementation","testosterone","INTERVENTIONAL","OTHER",[26],"NA",{"count":28,"type":29},60,"ESTIMATED",[31,36],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DIETARY_SUPPLEMENT","Qualia Testosterone","Qualia Testosterone manufactured by Qualia Life Sciences",[33],{"type":32,"name":37,"description":38,"armGroupLabels":39},"Placebo","Rice Flour",[37],[41],{"measure":42,"description":43,"timeFrame":44},"Between-group change in blood testosterone levels","To assess the between-group differences in change from baseline to Week 3 in Total Testosterone, Free (Dialysis) Testosterone, and Dihydrotestosterone levels following Qualia Testosterone supplementation.","3 weeks",[46,50],{"measure":47,"description":48,"timeFrame":49},"Aging Male Symptoms Scale scores","To evaluate between-group changes in Overall, Psychological, Somatic, and Sexual scores on the Aging Male Symptoms Scale from baseline to Week 3","Week 3",{"measure":51,"description":52,"timeFrame":53},"Side effect profile as measured by a custom Safety and Tolerability survey","Number of participants with treatment-related adverse events as assessed by a score of 3 or greater on the Safety and Tolerability survey","Week 1, 2 and 3","MALE","28 Years","65 Years",true,{"inclusion":59,"exclusion":60,"raw_text":61},[],[],"Inclusion criteria:\n\nProvide voluntary, written, informed consent to participate in the study Agree to provide a valid cell phone number and are willing to receive communications through text Can read and write English Willing to not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly Willing to complete questionnaires, records, and diaries associated with the study.\n\nMale participants aged 28-65 A score ≥27 on the Aging Males Symptom Scale Willing and able to visit a local blood draw facility for required blood sample collections Live within 20 miles of a suitable blood draw facility Willing to not consume any supplements containing Testosterone starting about 2 weeks prior to the baseline blood test test continuing through the intervention period.\n\nExclusion criteria:\n\nKnown food intolerances\u002Fallergy to any ingredients in the product Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, cancer Having had a significant cardiovascular event in the past 6 months Taking MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines On immunosuppressive therapy Individuals who were deemed incompatible with the test protocol Adults lacking capacity to consent Have Hypogonadism",[63,64],"ADULT","OLDER_ADULT",[66],{"facility":13,"city":67,"state":68,"zip":69,"country":70,"contacts":71,"geoPoint":77},"Carlsbad","California","92011","United States",[72],{"name":73,"role":74,"phone":75,"email":76},"Abhi Ardagh","CONTACT","855-281-2328","support@qualialife.com",{"lat":78,"lon":79},33.15809,-117.35059,[81],{"name":82,"role":74,"phone":75,"email":76},"William Scuba",[],[],[],{"nct_id":4,"conditions":87,"biomarkers":89},[88],"Testosterone Deficiency, CTCAE",[],{"nct_id":4,"found":57,"summary":91,"prompt_version":101},{"design":92,"status":93,"heading":94,"summary":95,"follow_up":96,"word_count":97,"commitments":98,"compensation":99,"drugs_mentioned":100},"This is a randomized, double-blind (meaning neither you nor your doctor will know if you're getting the active supplement or placebo), placebo-controlled study involving about 60 participants.","completed","Qualia Testosterone Supplement for Low Testosterone","This study is looking at how well a dietary supplement called Qualia Testosterone works in men aged 28 to 65 who have symptoms of low testosterone. About 60 men will take either Qualia Testosterone or a placebo (an inactive substance like rice flour) for 21 days. Researchers will measure your blood testosterone levels after 3 weeks to see if the supplement helps. They will also look at how your symptoms of aging change and check for any side effects. The study is currently unclear on its recruitment status.","Your blood testosterone levels will be measured at 3 weeks after starting the intervention.",88,"You would take 2 capsules daily for 21 days, complete questionnaires, and have your blood testosterone levels measured at 3 weeks.","Not stated in the trial record.",[33,37],"v2"]