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NCT Number: NCT03586414

MitoQ Supplementation and Cardiovascular Function in Healthy Men and Women

In this pilot study, the investigators will determine whether supplementation with a mitochondrial-targeted antioxidant (Mitoquinone (MitoQ)) improves mitochondrial function, left ventricular diastolic and vascular function.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Diastolic Dysfunction

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado

Aurora, Colorado, 80045, United States

About this study

Heart failure affects over 5 million American adults and the risk of heart failure increases with age. Diastolic function typically declines with age. Targeting age-related causal factors leading to the decline in diastolic function in both women and men is a major public health initiative. In this pilot study, the investigators will determine whether supplementation with a mitochondrial-targeted antioxidant (Mitoquinone (MitoQ)) improves mitochondrial function, left ventricular diastolic and vascular function in older adults. As an exploratory aim, the investigators will determine whether there are differences between men and women in response to this supplementation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 50 - 75 years of age
  • sedentary-to-recreationally active (<3 days of vigorous exercise);
  • nonsmokers;
  • healthy, as determined by medical history, physical examination, standard blood chemistries.

Exclusion criteria

  • history of cancer
  • history of cardiovascular disease
  • unwilling or unable to take MitoQ supplement;
  • taking antioxidant vitamins, corticosteroids, or anti-inflammatory medications (e.g., aspirin);
  • taking sex hormone therapy
  • presence of menses within last 1 year;
  • taking any other medications (e.g., antihypertensives, lipid lowering medications) that would interact with MitoQ or impact CV function

Treatment and study plan

MITOQUINOL MESYLATE then placebo

Dietary Supplement

MITOQUINOL MESYLATE then placebo: 'MITOQUINOL MESYLATE' administered twice daily for 4 weeks followed by a washout, then placebo capsule administered twice daily for 4 weeks. Capsules with active product contain 20 mg of 'MITOQUINOL MESYLATE'.

Other names: MitoQ, Mitoquinol methanesulfonate

Placebo, then MITOQUINOL MESYLATE

Dietary Supplement

'Placebo, then MITOQUINOL MESYLATE' : Placebo administered twice daily for 4 weeks followed by a washout, then 'MITOQUINOL MESYLATE' capsule administered twice daily for 4 weeks. Capsules with active product contain 20 mg of 'MITOQUINOL MESYLATE'.

Other names: MitoQ, Mitoquinol methanesulfonate

Primary outcomes

  1. Changes in diastolic function

    Time frame: Baseline and 4 weeks

    Echocardiographic measurements of LV function (and structure) will be assessed; primary outcomes include peak early (E) to late (A) mitral inflow velocity ratio and E to peak early (e') mitral annular velocity ratio.

Secondary outcomes

  1. Changes in arterial stiffness

    Time frame: Baseline and 4 weeks

    Parameters of arterial stiffness will be measured using SphygmoCor XCEL (Atcor) system (pulse-wave velocity [PWV], pulse wave analyses [PWA]).

  2. Changes in brachial artery flow-mediated dilation

    Time frame: Baseline and 4 weeks

    Brachial artery diameter and flow velocity will be acquired and analyzed using Vascular Analysis Tools 5.5.1

  3. Changes in endothelial function

    Time frame: Baseline and 4 weeks

    Measure parameters using digital peripheral arterial tonometry (Endo-PAT 2000)

  4. Changes in arterial vascular coupling

    Time frame: Baseline and 4 weeks

    Measure ratio between arterial stiffness [Ea] and ventricular stiffness [ELv] estimated from echocardiographic measures.

  5. Changes in mitochondrial function

    Time frame: Baseline and 4 weeks

    Measure parameters of mitochondrial respiration using high-resolution respirometry performed on permeabilized PBMCs (Oroboros Oxygraph O2k); perform venous endothelial cell mitochondrial protein analyses (Fusion, Fission proteins, SIRT1, mitoSox, MnSOD) and oxidative stress (nitrotyrosine, NADPHoxidase).

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • University of Colorado Nutrition Obesity Research Center (NORC)

Registry information

Official study title

Mitochondrial Targeted Antioxidant Supplementation and Diastolic Function in Healthy Men and Women

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Jul 13, 2018
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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