MitoQ Supplementation and Cardiovascular Function in Healthy Men and Women

Not Applicable

Active, not recruiting

• Conditions: Diastolic Dysfunction
• Interventions: Dietary Supplement: MITOQUINOL MESYLATE then placebo; Dietary Supplement: Placebo, then MITOQUINOL MESYLATE

• Registration Number: NCT03586414
• Lead Sponsor: University of Colorado, Denver

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.

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 Timeline

• Study First Submitted: 2018-02-21
• Study First Submitted QC: 2018-07-02
• Study First Posted: 2018-07-13
• Study Start: 2021-08-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-07
• Primary Completion: 2030-07
• Study Completion: 2030-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A: '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'.
B: Placebo then 'MITOQUINOL MESYLATE'	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'

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Changes in endothelial function	Baseline and 4 weeks	Measure parameters using digital peripheral arterial tonometry (Endo-PAT 2000)
Changes in arterial vascular coupling	Baseline and 4 weeks	Measure ratio between arterial stiffness \[Ea\] and ventricular stiffness \[ELv\] estimated from echocardiographic measures.
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
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).
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 \[PWA\]).

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Aurora, Colorado, United States