MitoQ and Exercise Effects on Vascular Health

What this trial studies

An impairment in vascular function can lead to the development of age-associated cardiovascular disease (CVD), the leading cause of death in postmenopausal women. Regular aerobic exercise (AE) benefits vascular function in older men by reducing oxidative stress, however, similar AE training improvements are diminished or absent in postmenopausal women. not using estrogen-based hormone therapy. Vascular function and oxidative stress are improved with AE training in postmenopausal women treated with E2, suggesting an essential role of E2 in vascular adaptations to AE in women.

Conditions in scope

• Aging
• Menopause

Interventions

• MitoQ (Dietary Supplement) — MitoQ is a biochemically modified form of ubiquinol
• Placebo (Dietary Supplement) — Each placebo capsule contains inert excipient and is identical in appearance
• Aerobic exercise (Behavioral) — Moderate intensity aerobic exercise on the treadmill

Who can join

Women only · Ages 50 Years to 120 Years · Accepts healthy volunteers.

Inclusion criteria

• resting blood pressure \<140/90 mmHg;
• fasted glucose \<126 mg/dL;
• sedentary/recreationally active (\<2 days/wk vigorous exercise);
• healthy, as determined by medical history, physical examination, standard blood chemistries (chemistry panel, CBC and circulating thyroid levels) and ECG at rest and during exercise;
• nonsmokers;
• no use of medications that might influence cardiovascular function (i.e., antihypertensive, lipid lowering medications, blood thinners);
• no use of vitamin supplements or anti-inflammatory medications, or willing to stop 1 month prior to enrollment and for the duration of the study;
• no use of HT for at least 6 months;

Exclusion criteria

• Volunteers will be excluded from the study if they have contraindications to MitoQ or AE.
• acute liver disease, history of venous thromboembolic events, preexisting or active cardiac, renal or hepatic disease, history of stomach ulcer or bleeding or epilepsy or other seizure disorder;
• diabetes, active infection, disease that affects the nervous system,
• an abnormal resting ECG, angina and/or ECG evidence of acute myocardial ischemia during the exercise test (development of ST-segment depression of more than 0.3 mV that is either horizontal, down-sloping, or slowly upsloping -less than 1 mvolt/sec and lasts more than 0.08 sec; ST elevation; chest pain or discomfort), bundle branch blocks, A-V block greater than first degree, arrhythmias;
• chronic infections;
• thyroid dysfunction, defined as an ultrasensitive TSH \<0.5 or \>5.0 mU/L; volunteers with abnormal TSH values will be re-considered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement;
• orthopedic or other problems that would interfere with participation in the exercise program
• The volunteers who choose to participate will do so with the understanding that they will be randomly assigned to study groups that involve either AE+PL (33% chance), No AE+MitoQ (33% chance) or AE+MitoQ (33% chance).

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Active, not recruiting
• Study type: Interventional
• Phase: EARLY_PHASE1
• Start date: 2023-01-16
• Primary completion: 2024-09-30
• Last update posted: 2025-03-25
• First posted: 2023-01-17

Sponsor & contact

Lead sponsor: University of Colorado, Denver (Other)

Collaborators: National Institute on Aging (NIA)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Change from baseline Endothelial function at 10 weeks (Baseline and after 10 weeks)
  Brachial artery flow-mediated dilation

Related ClearedRx care

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