{"type":"trials","record":{"id":38837,"source_id":"clinicaltrials-gov","external_id":"NCT01384591","title":"Pilot Study of Losartan and N-acetylcysteine as Inhibitors of Muscle Oxidative Stress in Elderly","brief_summary":"The general hypothesis is that elderly have diminished nutritive flow to skeletal muscle and impaired capacity for building muscle. In aging populations, this decreased ability to build muscle may represent a tipping point in the progression towards chronic physical frailty and disability. The goal is to examine whether novel pharmacologic therapies can improve nutritive blood flow to the muscles and muscle building in the elderly. The purpose of this study is 1) to determine if losartan administration will enhance blood flow and 2) to determine if N-acetylcysteine (NAC) will enhance blood flow. The investigators will study community dwelling, healthy older men and women (60-85 years). Subjects will be randomized to one of three groups: Experimental Group 1: Placebo losartan and placebo N-acetylcysteine (NAC). Experimental Group 2: losartan (25mg/dose) and placebo N-acetylcysteine (NAC). Experimental Group 3: N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo Subjects will admit to the clinic on day 1 of the study. Baseline testing consisting of leg blood flow (LBF), contrast enhanced ultrasound, handgrip testing and fatigue questionnaires. After testing is completed the subjects will recieve their first dose of NAC/ losartan/ placebo with dinner. Subjects will be fasted after 10 pm. On day 2, leg blood flow (LBF) will be measured approximately 12 hours post dose 1. Subjects will receive their second dose of NAC/ losartan/ placebo. Leg blood flow will be measured 1 hour and 2 hours post dose 2 of study interventions. The subjects will eat a meal and receive their third dose of the study intervention. Leg blood flow will be repeated at 1 hour and 2 hours post dose 3. Appoximately 30 minutes after dose 3 of the study intervention, handgrip testing will be performed and fatigue questionnaires completed.","overall_status":"Completed","phases":["PHASE1","PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"The University of Texas Medical Branch, Galveston","enrollment":6,"countries":["United States"],"start_date":"2011-07-01","completion_date":"2015-05-01","last_update_date":"2018-05-08","source_url":"https://clinicaltrials.gov/study/NCT01384591","editorial_summary":"A registered PHASE1, PHASE2 study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:25:10.04816+00:00","last_seen_at":"2026-09-25T06:15:54.38+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"60 Years to 85 Years","comparator":"Placebo losartan and placebo N-acetylcysteine","organization":"The University of Texas Medical Branch, Galveston","interventions":["N-acetylcysteine","Losartan","Placebo losartan","Placebo N-acetylcysteine"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Leg Blood Flow as Measured by Doppler Ultrasound — Baseline","Leg Blood Flow as Measured by Doppler Ultrasound — 12 hours post dose one of the intervention","Leg Blood Flow as Measured by Doppler Ultrasound — 1 hour post dose two of the intervention, average of 13 hours post d…","Leg Blood Flow as Measured by Doppler Ultrasound — 2 hours post dose two of the intervention, average of 14 hours post…","Leg Blood Flow as Measured by Doppler Ultrasound — Post dose three of the intervention and a meal, average of 17 hours…","Leg Blood Flow as Measured by Doppler Ultrasound — 1 hour post dose three of the intervention and a meal, average of 18…","Leg Blood Flow as Measured by Doppler Ultrasound — 2 hours post dose three of the intervention and a meal, average of 1…","Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort at Baseline — baseline","Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort at Baseline — baseli…","Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 100% Effort at Baseline — baseline","Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 100% Effort at Baseline — baseline","Handgrip Fatigue of Dominant Hand as Measured by Handgrip Dynamometry at Baseline — baseline","Handgrip Fatigue of Non-dominant Hand as Measured by Handgrip Dynamometry at Baseline — baseline","Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort After All Doses of Study…","Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort After All Doses of S…","Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 100% Perceived Effort After All Doses of Stud…","Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 100% Perceived Effort After All Doses of…","Handgrip Fatigue of Dominant Hand as Measured by Handgrip Dynamometry After All Doses of Study Intervention — Post dose…","Handgrip Fatigue of Non-dominant Hand as Measured by Handgrip Dynamometry After All Doses of Study Intervention — Post…","Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale General Fatigue at Baseli…"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","source_has_results":true},"controlled_terms":["Aging","N-acetylcysteine","Losartan","Placebo losartan","Placebo N-acetylcysteine"],"relevance_confidence":80,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Title contains controlled term: oxidative stress.","quality_checked_at":"2026-09-25T06:16:07.48358+00:00","duplicate_cluster_key":"id:nct01384591","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2011-07-01 to 2015-05-01","comparator":"Placebo losartan and placebo N-acetylcysteine","confidence":"structured-source","population":"ALL · 60 Years to 85 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:15:54.489Z","intervention":["N-acetylcysteine","Losartan","Placebo losartan","Placebo N-acetylcysteine"],"participants":6,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE1, PHASE2","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Leg Blood Flow as Measured by Doppler Ultrasound — Baseline","Leg Blood Flow as Measured by Doppler Ultrasound — 12 hours post dose one of the intervention","Leg Blood Flow as Measured by Doppler Ultrasound — 1 hour post dose two of the intervention, average of 13 hours post d…","Leg Blood Flow as Measured by Doppler Ultrasound — 2 hours post dose two of the intervention, average of 14 hours post…","Leg Blood Flow as Measured by Doppler Ultrasound — Post dose three of the intervention and a meal, average of 17 hours…","Leg Blood Flow as Measured by Doppler Ultrasound — 1 hour post dose three of the intervention and a meal, average of 18…","Leg Blood Flow as Measured by Doppler Ultrasound — 2 hours post dose three of the intervention and a meal, average of 1…","Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort at Baseline — baseline","Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort at Baseline — baseli…","Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 100% Effort at Baseline — baseline","Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 100% Effort at Baseline — baseline","Handgrip Fatigue of Dominant Hand as Measured by Handgrip Dynamometry at Baseline — baseline","Handgrip Fatigue of Non-dominant Hand as Measured by Handgrip Dynamometry at Baseline — baseline","Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort After All Doses of Study…","Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort After All Doses of S…","Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 100% Perceived Effort After All Doses of Stud…","Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 100% Perceived Effort After All Doses of…","Handgrip Fatigue of Dominant Hand as Measured by Handgrip Dynamometry After All Doses of Study Intervention — Post dose…","Handgrip Fatigue of Non-dominant Hand as Measured by Handgrip Dynamometry After All Doses of Study Intervention — Post…","Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale General Fatigue at Baseli…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"oxidative-stress","is_published":true,"match_reasons":["Title contains controlled term: oxidative stress.","Title supplies longevity context: elderly.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","title context","study type"],"relevance_score":80,"intelligence_topics":{"name":"Oxidative stress","slug":"oxidative-stress"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/38837","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}