Pilot Study of Losartan and N-acetylcysteine as Inhibitors of Muscle Oxidative Stress in Elderly
Status:
Completed
Trial end date:
2015-05-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Collaborators:
Lantheus Medical Imaging National Institutes of Health (NIH)