MitoQ Supplementation and Cardiovascular Function in Healthy Men and Women

Diastolic Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03586414
• Other study ID #: 17-1782
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: August 2025

Study information

• Verified date: November 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31
• Est. completion date: August 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diastolic Dysfunction

Intervention

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'.
• 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'.

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	University of Colorado Nutrition Obesity Research Center (NORC)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Changes in endothelial function	Measure parameters using digital peripheral arterial tonometry (Endo-PAT 2000)	Baseline and 4 weeks
Secondary	Changes in arterial vascular coupling	Measure ratio between arterial stiffness [Ea] and ventricular stiffness [ELv] estimated from echocardiographic measures.	Baseline and 4 weeks
Secondary	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