MitoQ Supplementation and Cardiovascular Function in Healthy Men and Women

NCT ID: NCT03586414

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2030-08-31

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.

Conditions

Diastolic Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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'.

Group Type: EXPERIMENTAL

MITOQUINOL MESYLATE then placebo

Intervention Type: 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'.

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'

Group Type: EXPERIMENTAL

Placebo, then MITOQUINOL MESYLATE

Intervention Type: 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'.

Interventions

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'.

Intervention Type: 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'.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

MitoQ, Mitoquinol methanesulfonate; MitoQ, Mitoquinol methanesulfonate

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado Nutrition Obesity Research Center (NORC)

UNKNOWN

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shauna Runchey, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado

Aurora, Colorado, United States

Countries

United States

Other Identifiers

17-1782

Identifier Type: -

Identifier Source: org_study_id