Diastolic Dysfunction
Conditions
Keywords
MitoQ
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.
Interventions
DIETARY_SUPPLEMENTMITOQUINOL 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'.
DIETARY_SUPPLEMENTPlacebo, 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'.
Sponsors
University of Colorado Nutrition Obesity Research Center (NORC)
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 \[PWA\]). |
| 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 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 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). |
Countries
United States
Outcome results
None listed