MitoQ Supplementation and Cardiovascular Function in Healthy Men and Women

Mitochondrial Targeted Antioxidant Supplementation and Diastolic 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diastolic Dysfunction
• Intervention / Treatment: Dietary supplement: MITOQUINOL MESYLATE then placebo; Dietary supplement: Placebo, then MITOQUINOL MESYLATE

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in diastolic function	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.	Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in arterial stiffness	Parameters of arterial stiffness will be measured using SphygmoCor XCEL (Atcor) system (pulse-wave velocity [PWV], pulse wave analyses [PWA]).	Baseline and 4 weeks
Changes in brachial artery flow-mediated dilation	Brachial artery diameter and flow velocity will be acquired and analyzed using Vascular Analysis Tools 5.5.1	Baseline and 4 weeks
Changes in endothelial function	Measure parameters using digital peripheral arterial tonometry (Endo-PAT 2000)	Baseline and 4 weeks
Changes in arterial vascular coupling	Measure ratio between arterial stiffness [Ea] and ventricular stiffness [ELv] estimated from echocardiographic measures.	Baseline and 4 weeks
Changes in mitochondrial function	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).	Baseline and 4 weeks

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: University of Colorado Nutrition Obesity Research Center (NORC)
• Investigators: Principal Investigator: Shauna Runchey, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: February 21, 2018
• First Submitted That Met QC Criteria: July 2, 2018
• First Posted (Actual): July 13, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: MitoQ
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Ubiquinone
• Other Study ID Numbers: 17-1782

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pending

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No