Mitochondrial-Targeted Antioxidant Supplementation for Improving Cerebrovascular Function in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Change from baseline in cerebrovascular conductance at 3 months
研究概览
简要总结
The goal of this clinical trial is to learn if 3 months of taking the dietary supplement MitoQ [a mitochondria-targeted antioxidant that targets to reduce mitochondrial reactive oxygen species (mitoROS)] works to treat age- and menopause-related reductions in brain artery (cerebrovascular) function in postmenopausal women 60 years of age or older free of clinical disease. The main questions it aims to answer are:
Does MitoQ improve cerebrovascular function in postmenopausal women?
If so, does MitoQ improve cerebrovascular function by lowering mitoROS in these arteries?
Researchers will compare MitoQ to a placebo (a look-alike substance that contains no drug) to see if MitoQ can improve cerebrovascular function by lowering mitoROS in arteries involved in brain health and function.
Participants will:
Take MitoQ (20 mg/day) or a placebo every day for 3 months
Visit the research laboratory at baseline and then after 3 months for cerebrovascular testing; there is also a check-in visit at 6 weeks, which is the halfway point
Keep track of symptoms and events during their treatment period to report to the study team
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 60 years or older;
- •Postmenopausal women defined as at least 1 year without menses as self-reported;
- •Estrogen-deficient; no hormone therapies (e.g., estrogen, progesterone, testosterone, DHEA, oral contraceptives, etc.) within the previous 6 months;
- •Ability to provide informed consent;
- •Willing to accept random assignment to condition;
- •Body mass index (BMI) ≤35 kg/m2;
- •Mini-mental state examination score ≥21;
- •Weight stable in the prior 3 months;
- •Abstinence from antioxidant or CoQ10 therapy for 3 months; and
- •Absence of clinical disease as determined by the physician of record following a medical history and blood chemistries
排除标准
- •History of uncontrolled hypertension;
- •Currently meeting aerobic exercise guidelines of ≥75 mins/week of vigorous or ≥150 mins/week of moderate intensity exercise as assessed by Modified Activity Questionnaire;
- •Current smoker;
- •Alcohol dependence or abuse;
- •Other chronic medical conditions; and
- •Subject report of blood donation within 8 weeks prior to enrolling.
研究组 & 干预措施
MitoQ, 20 mg/day
Each MitoQ capsule contains 20 mg of mitoquinol mesylate. Dosage: 20 mg orally per day for 3 months.
干预措施: Mitoquinone (MitoQ) (Dietary Supplement)
Placebo
Matched placebo capsules.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change from baseline in cerebrovascular conductance at 3 months
时间窗: 3 months
Middle cerebral artery blood velocity in response to hypercapnia normalized for changes in end-tidal carbon dioxide and blood pressure
次要结局
- Change from baseline in cerebrovascular reactivity at 3 months(3 months)
- Change from baseline in mitochondrial oxidative stress-mediated suppression of cerebrovascular conductance at 3 months(3 months)
- Change from baseline in mitochondrial oxidative stress-mediated suppression of cerebrovascular reactivity at 3 months(3 months)
- Change from baseline in internal carotid artery dilation in response to hypercapnia at 3 months(3 months)
- Change from baseline in mitochondrial oxidative stress-mediated suppression of internal carotid artery dilation at 3 months(3 months)
- Change from baseline in total cerebral blood flow at 3 months(3 months)
- Change from baseline in cerebrovascular stiffness at 3 months(3 months)
- Change from baseline in carotid artery compliance at 3 months(3 months)
- Change from baseline in mitochondrial oxidative stress-mediated suppression of carotid artery compliance at 3 months(3 months)