NCT04351113

Targeting Oxidative Stress to Prevent Vascular and Skeletal Muscle Dysfunction During Disuse

Recruiting now NA Last updated 23 April 2025

What this trial tests

NA trial testing MITO-AO in Aging in 72 participants. Currently enrolling.

Timeline

1 September 2019

Primary endpoint
31 December 2025

31 December 2025

Quick facts

Lead sponsor	Joel Trinity
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	diagnostic
Enrollment	72
Start date	1 September 2019
Primary completion	31 December 2025
Estimated completion	31 December 2025
Sites	1 location across United States

Drugs / interventions tested

• MITO-AO
• PB-125
• Placebo
• Passive Leg Movement (PLM)
• Plantar flexion
• Isometric knee extensor test
• Bed rest

Conditions studied

• Aging — all drugs for Aging →
• Oxidative Stress — all drugs for Oxidative Stress →
• Vascular Endothelium — all drugs for Vascular Endothelium →
• Skeletal Muscle — all drugs for Skeletal Muscle →

Sponsor

Joel Trinity

Who can join

Adults 65 to 85, any sex, with Aging or Oxidative Stress. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Prolonged periods of reduced activity are associated with decreased vascular function and muscle atrophy. Physical inactivity due to acute hospitalization is also associated with impaired recovery, hospital readmission, and increased mortality. Older adults are a particularly vulnerable population as functional (vascular and skeletal muscle mitochondrial dysfunction) and structural deficits (loss in muscle mass leading to a reduction in strength) are a consequence of the aging process. The combination of inactivity and aging poses an added health threat to these individuals by accelerating the negative impact on vascular and skeletal muscle function and dysfunction. The underlying factors leading to vascular and skeletal muscle dysfunction are unknown, but have been linked to increases in oxidative stress. Additionally, there is a lack of understanding of how vascular function is impacted by inactivity in humans and how these changes are related to skeletal muscle function. It is our goal to investigate the mechanisms that contribute to disuse muscle atrophy and vascular dysfunction in order to diminish their negative impact, and preserve vascular and skeletal muscle function across all the lifespan.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Vitreous Humor Proteome: Targeting Oxidative Stress, Inflammation, and Neurodegeneration in Vitreoretinal Diseases.
   Santos FM, Mesquita J, Castro-de-Sousa JP, Ciordia S, et al · · 2022 · cited 23× · PMID 35326156 · DOI 10.3390/antiox11030505