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

This study is looking at ways to prevent problems with blood vessels and muscles that can happen when older adults are less active, for example, during a hospital stay. Researchers are testing two dietary supplements, MITO-AO and PB-125, against a placebo (an inactive substance). You would receive one of these for five days while experiencing a period of reduced activity. The study aims to see if these supplements can improve blood vessel health and blood flow. To join, you should be between 65 and 85 years old, able to give informed consent, and have a Montreal Cognitive Assessment (MOCA) score of 26 or higher. The study plans to enroll 82 participants.

Study design: This interventional study plans to enroll 82 participants. It is designed to compare the effects of two dietary supplements (MITO-AO and PB-125) against a placebo.
What's involved: You would receive a dietary supplement or placebo for 5 days. You would also undergo tests for passive leg movement and plantar flexion at different times, including before, during, and after the period of reduced activity.
Compensation: Not stated in the trial record.
Follow-up: Blood vessel changes will be measured at 10 days after the start of the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Completed

NAAges 65–85InterventionalDiagnostic

Joel Trinity

~82 participants

Updated 2026-09-08 on ClinicalTrials.gov

What's tested:MITO-AOPB-125PlaceboPassive Leg Movement (PLM)Plantar flexionIsometric knee extensor test

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in blood vessel diameter after PLM

Measured over 10 days

+1 more outcome measured

Conditions

Aging

Oxidative Stress

Vascular Endothelium

Skeletal Muscle

Antioxidants

NCT04351113

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

VA Medical Center
Salt Lake City, Utahno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Age between 65-85 yrs

Ability to sign informed consent

Montreal cognitive assessment (MOCA) exam score greater-than or equal to 26 4. Free-living, prior to admission

Exclusion

Cardiac abnormalities considered exclusionary by the study physician (e.g., congestive heart failure (CHF), coronary artery disease (CAD), right-to-left shunt)

Uncontrolled endocrine or metabolic disease (e.g., hypo/hyperthyroidism, diabetes)

Glomerular filtration rate (GFR) less-than 30 mL/min/1.73m2 or evidence of kidney disease or failure

Vascular disease or risk factors of peripheral atherosclerosis. (e.g., uncontrolled hypertension, obesity, diabetes, hypercholesterolemia greater-than 250 mg/dl, claudication or evidence of venous or arterial insufficiency upon palpitation of femoral, popliteal and pedal arteries)

Risk of deep vein thrombosis (DVT) including family history of thrombophilia, DVT, pulmonary emboli, myeloproliferative diseases including polycythemia (Hb greater-than 18 g/dL) or thrombocytosis (platelets greater-than 400x103/mL), and connective tissue diseases (positive lupus anticoagulant), hyperhomocysteinemia, deficiencies of factor V Leiden, proteins S and C, and antithrombin III

Use of anticoagulant therapy (e.g., Coumadin, heparin)

Elevated systolic pressure greater-than 150 or a diastolic blood pressure greater-than 100 (treated or untreated)

Implanted electronic devices (e.g., pacemakers, electronic infusion pumps, stimulators)

Cancer or history of successfully treated cancer (less than 1 year) other than basal cell carcinoma

Currently on a weight-loss diet or body mass index greater-than 35 kg/m2 (a BMI of 35 kg/m2, which includes individuals that fall into to the Class I obesity category, has been selected to improve inclusion and generalizability to a greater percentage of the general population).

Inability to abstain from smoking for duration of study

A history of greater-than 20 pack per year smoking

HIV or hepatitis B or C\*

Recent anabolic or corticosteroids use (within 3 months)

Subjects with hemoglobin or hematocrit lower than accepted lab values

Agitation/aggression disorder (by psychiatric history and exam)

History of stroke with motor disability

A recent history (less-than 12 months) of GI bleed

Depression \[greater-than 5 on the 15 items Geriatric Depression Scale (GDS)\]

Alcohol abuse (greater-than 2 drinks per day) or drug abuse (inappropriate use of prescription medications or use of any illicit/illegal drugs for recreational use)

Exercise training (greater-than 1 session of moderate to high intensity aerobic or resistance exercise/week)

Liver disease (aspartate aminotransferase/alanine aminotransferase 2 times above the normal limit, hyperbilirubinemia)

Respiratory disease (acute upper respiratory infection, history of chronic lung disease with resting oxygen saturation less-than 97% on room air)

Currently taking a mitochondrial targeted antioxidant or similarly acting nutraceutical

Unwilling to cease dietary supplements 4 weeks prior to initiation of bed rest

Participated in similar bed rest study during last 12 months

Any other condition or event considered exclusionary by the PI and faculty physician

What this trial measures

Change in blood vessel diameter after PLM10 days
Change in blood vessel flow rate after PLM10 days

Trialytics