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MitoQ Supplementation and Cardiovascular Function in Healthy Men and Women

Sponsor
University of Colorado, Denver (Other)
Overall Status
Recruiting
CT.gov ID
NCT03586414
Collaborator
University of Colorado Nutrition Obesity Research Center (NORC) (Other)
60
Enrollment
1
Location
2
Arms
36
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: MITOQUINOL MESYLATE then placebo
  • Dietary Supplement: Placebo, then MITOQUINOL MESYLATE
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Mitochondrial Targeted Antioxidant Supplementation and Diastolic Function in Healthy Men and Women
Actual Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: A: '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'.

Dietary Supplement: MITOQUINOL MESYLATE then placebo
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

    		•
    Experimental: B: Placebo then 'MITOQUINOL MESYLATE'

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

    Dietary Supplement: Placebo, then MITOQUINOL MESYLATE
    '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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in diastolic function [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 Outcome Measures

    1. Changes in arterial stiffness [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 [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 [Baseline and 4 weeks]

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

    4. Changes in arterial vascular coupling [Baseline and 4 weeks]

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

    5. Changes in mitochondrial function [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. 50 - 75 years of age

    2. sedentary-to-recreationally active (<3 days of vigorous exercise);

    3. nonsmokers;

    4. healthy, as determined by medical history, physical examination, standard blood chemistries.

    Exclusion Criteria:

    1. history of cancer

    2. history of cardiovascular disease

    3. unwilling or unable to take MitoQ supplement;

    4. taking antioxidant vitamins, corticosteroids, or anti-inflammatory medications (e.g., aspirin);

    5. taking sex hormone therapy

    6. presence of menses within last 1 year;

    7. taking any other medications (e.g., antihypertensives, lipid lowering medications) that would interact with MitoQ or impact CV function

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Colorado Aurora Colorado United States 80045

    Sponsors and Collaborators

    • University of Colorado, Denver
    • University of Colorado Nutrition Obesity Research Center (NORC)

    Investigators

    • Principal Investigator: Shauna Runchey, MD, University of Colorado, Denver

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT03586414
    Other Study ID Numbers:
    • 17-1782
    First Posted:
    Jul 13, 2018
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Colorado, Denver
    MitoQ
    Additional relevant MeSH terms:
    Ubiquinone

    Study Results

    No Results Posted as of Aug 23, 2022