Mitochondria Oxidative Stress and Vascular Health Study

NCT05561556 | Completed

• 1 other identifier: AU IRB #22-154
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiovascular diseases (CVDs) are the number one cause of death in America and most of the post-industrial world. Hypertension is a leading risk factor for CVDs including stroke, myocardial infarction, and heart failure. Black Americans suffer from the highest rates of hypertension of any racial/ethnic group in America, among the highest in the world. There are also well-documented racial disparities in vascular dysfunction (e.g., endothelial dysfunction, arterial stiffening). Thus, racial disparities in hypertension and vascular dysfunction exacerbate the burden of CVDs, with Black Americans being 30% more likely to die from CVD than any other race in the US. It is established that mitochondrial dysfunction contributes to vascular dysfunction. However, there is a knowledge gap regarding whether targeting mitochondrial dysfunction attenuates oxidative stress, vascular dysfunction, and CVD risk among Black adults at heightened CVD risk. Thus, the investigators will conduct an 8-week trial with the mitochondrial antioxidant MitoQ in middle-aged and older Black and non-Black adults. Our overarching hypothesis is that mitochondrial dysfunction contributes to heightened oxidative stress, vascular dysfunction, and higher BP in Black adults; and that MitoQ will attenuate these racial differences. Importantly, the investigators will also assess social determinants of health (e.g., income, neighborhood disadvantage, discrimination) and health behaviors (e.g., diet, physical activity) and uncover their role in oxidative stress, vascular function, and BP Regarding methodology, the investigators will perform blood draws, vascular testing, preceding and following an 8-week, 20mg daily consumption of MitoQ and placebo. The investigators will also measure urine biomarkers of kidney function and blood pressure in adults (45-75 years old).

Conditions

Cardiovascular Diseases; Hypertension; Racism; Vascular Diseases

Keywords

Cardiovascular health; Hypertension; Health disparities; Renal function; Vascular health

Outcome Measures

Primary Outcomes (6)

• Changes in flow-mediated dilation (FMD)

  Flow-mediated vasodilation will be assessed using continuous measures of brachial artery diameter and velocity via duplex Doppler ultrasound (Hitachi Arietta 70). The brachial artery will be imaged in the longitudinal plane proximal to the medial epicondyle using a high-frequency (6-12 MHz) linear-array probe. The ultrasound probe will be stabilized using a custom-built clamp. Shear rate (sec-1) will be calculated as \[(blood flow velocity (cm\*s-1) \*4)/blood vessel diameter (mm)\] The image will be recorded throughout a 60-s baseline, a 300-s ischemic stimulus (250 mmHg), and 180 seconds post deflation. FMD will be expressed as % dilation (final diameter-baseline diameter/baseline diameter x 100) and also normalized to the shear stimulus. Allometric scaling will be used if appropriate, including if there are baseline differences in artery diameter by race or condition.

  Changes from before and after 8 week supplementation and placebo

• Changes in pulse wave analysis (PWA)

  The investigators will use the SphygmoCor XCEL system to assess pulse wave analysis (PWA). A high-fidelity strain-gauge transducer is used to obtain the pressure waveform at the brachial pulse. PWA will be expressed as % (calculated as augmentation pressure divided by the pulse pressure).

  Changes from before and after 8 week supplementation and placebo

• Changes in pulse wave velocity (PWV)

  The investigators will use the SphygmoCor XCEL to assess pulse wave velocity (PWV). Distances from the carotid artery sampling site to the femoral artery (upper leg instrumented with a thigh cuff for oscillometric sphygmomanometry), and from the carotid artery to the suprasternal notch will be recorded. PWV will be expressed as cm/s

  Changes from before and after 8 week supplementation and placebo

• Changes in blood pressure reactivity

  The investigators will measure systolic and diastolic pressure using photoplethysmography at the finger. Systolic and diastolic blood pressure will be assessed at rest and during handgrip exercise. Blood pressure reactivity will be expressed as a change in pressure (mmHg) from baseline to a predetermined time during the stressor (e.g., minute one average and minute two average).

  Changes from before and after 8 week supplementation and placebo

• Changes in circulating reactive oxygen species

  The investigators will use electron paramagnetic resonance to measure reactive oxygen species (spectra units) in whole blood samples treated with a spin probe.

  Changes from before and after 8 week supplementation and placebo

• Changes in blood biomarkers of nitric oxide bioavailability

  The investigators will measure nitric oxide metabolites (nitrate and nitrite nanomolar concentration).

  Changes from before and after 8 week supplementation and placebo

Secondary Outcomes (14)

• Objective sleep duration

  Baseline pre-intervention (14-days)

• Objective sleep efficiency

  Baseline pre-intervention (14-days)

• Subjective sleep quality

  Baseline (pre-intervention)

• Subjective sleepiness

  Baseline (pre-intervention)

• Subjective sleep chronotype

  Baseline (pre-intervention)

Study Arms (2)

MitoQ

EXPERIMENTAL

8-week MitoQ supplementation (20 mg daily capsule).

Dietary Supplement: MitoQ

Placebo

PLACEBO COMPARATOR

8-week placebo matched in appearance to MitoQ supplementation (20 mg daily capsule).

Dietary Supplement: MitoQ

Interventions

MitoQ DIETARY_SUPPLEMENT

One 20mg capsule daily for 8 weeks

MitoQ; Placebo

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are between the ages of 45-75
• Have blood pressure no higher than 150/90 mmHg
• Have a BMI less than 40 Kg/m2 (otherwise healthy)
• Free from metabolic disease (diabetes or renal disease), pulmonary disorders (e.g., COPD \& cystic fibrosis), and cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular)
• Free of any medical issues that prevent participants from exercising (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis), giving blood (i.e., blood thinners), or allergies associated with MitoQ substances.

You may not qualify if:

• Known allergy to MitoQ
• High blood pressure - greater the 150/90 mmHg
• Low blood pressure - less than 90/50 mmHg
• History of cardiovascular disease
• History of cancer
• History of diabetes
• History of kidney disease
• Obesity (BMI \> 40 kg/m2)
• Current pregnancy
• Nursing mothers
• Communication barriers

Sponsors & Collaborators

• Auburn University: lead

Study Sites (1)

Auburn University

Auburn, Alabama, 36849, United States

Location

Related Publications (4)

• Gane EJ, Weilert F, Orr DW, Keogh GF, Gibson M, Lockhart MM, Frampton CM, Taylor KM, Smith RA, Murphy MP. The mitochondria-targeted anti-oxidant mitoquinone decreases liver damage in a phase II study of hepatitis C patients. Liver Int. 2010 Aug;30(7):1019-26. doi: 10.1111/j.1478-3231.2010.02250.x. Epub 2010 May 18.

  PMID: 20492507 BACKGROUND

• Snow BJ, Rolfe FL, Lockhart MM, Frampton CM, O'Sullivan JD, Fung V, Smith RA, Murphy MP, Taylor KM; Protect Study Group. A double-blind, placebo-controlled study to assess the mitochondria-targeted antioxidant MitoQ as a disease-modifying therapy in Parkinson's disease. Mov Disord. 2010 Aug 15;25(11):1670-4. doi: 10.1002/mds.23148.

  PMID: 20568096 BACKGROUND

• Rossman MJ, Santos-Parker JR, Steward CAC, Bispham NZ, Cuevas LM, Rosenberg HL, Woodward KA, Chonchol M, Gioscia-Ryan RA, Murphy MP, Seals DR. Chronic Supplementation With a Mitochondrial Antioxidant (MitoQ) Improves Vascular Function in Healthy Older Adults. Hypertension. 2018 Jun;71(6):1056-1063. doi: 10.1161/HYPERTENSIONAHA.117.10787. Epub 2018 Apr 16.

  PMID: 29661838 BACKGROUND

• Gioscia-Ryan RA, Battson ML, Cuevas LM, Eng JS, Murphy MP, Seals DR. Mitochondria-targeted antioxidant therapy with MitoQ ameliorates aortic stiffening in old mice. J Appl Physiol (1985). 2018 May 1;124(5):1194-1202. doi: 10.1152/japplphysiol.00670.2017. Epub 2017 Oct 26.

  PMID: 29074712 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Hypertension; Racism; Vascular Diseases

Interventions

mitoquinone

Condition Hierarchy (Ancestors)

Prejudice; Social Behavior; Behavior; Social Discrimination

Study Officials

• Austin T Robinson, PhD

  Kinesiology Building

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The member of the study team performing data analysis will be blinded when performing data analysis and unblinded after the final statistical analysis
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The intervention is to give participants an 8-week supplementation of one capsule (20 mg) of either a mitochondrial antioxidant (MitoQ) or a placebo (dextrin and silica), in a randomized order. Followed by a two-week washout, then another 8-week supplementation of a 20 mg capsule.

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 30, 2022
• Study Start: December 6, 2022
• Primary Completion: September 26, 2025
• Study Completion: September 26, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: One year after completion of the trial, indefinitely
• Access Criteria: A formal plan identifying the intended use of the data and proper completion of a DMDA and MTA (if needed) with Auburn University and the study PI.

Locations

US (1)