NCT02597023已完成不适用
The Efficacy of Oral Mitoquinone (MitoQ) Supplementation for Improving Physiological in Middle-aged and Older Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Endothelium-dependent dilation
研究概览
简要总结
The purpose of this study is to assess the efficacy of supplementation with the mitochondria-targeted antioxidant, mitoquinone (MitoQ), for improving physiological function (vascular, motor, and cognitive) in middle-aged and older adults.
详细描述
Overall, the proposed research project has the long-term potential to influence clinical practice by establishing novel therapies for treating multiple domains of age-associated physiological dysfunction and thereby reducing the risk of clinical disease and disability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women will be confirmed as postmenopausal (either natural or surgical) based on cessation of menses for >1 year.
- •Ability to provide informed consent
- •Baseline brachial flow-mediated dilation (FMD) < 6%Δ (rationale: non-invasive screening to ensure exclusion of subjects with exceptionally high baseline endothelial function.
- •Ability to perform motor and cognitive tests (e.g., can rise from a chair, walk for 2 min, climb 10 stairs)
- •Willing to accept random assignment to condition
排除标准
- •Current smoking
- •Having past or present alcohol dependence or abuse, as defined by the American Psychiatry Association, Diagnostic and Statistical Manual of Mental Disorders
- •Body mass index (BMI) >40 kg/m2 (FMD measurements can be inaccurate in severely obese patients)
- •Chronic clinical diseases (e.g., coronary artery/peripheral artery/cerebrovascular diseases, diabetes, chronic kidney disease requiring dialysis, neurological disorders or diseases that may affect motor/cognitive functions [multiple sclerosis, Parkinson's disease, polio, Alzheimer's disease, dementia or other brain diseases of aging]), except hypertension and hyperlipidemia
- •Regular vigorous aerobic/endurance exercise (>3 vigorous bouts/week).
- •Not weight stable in the prior 3 months (>2 kg weight change) or unwilling to remain weight stable throughout study (rationale: recent weight change or weight loss can influence vascular function.
- •Current treatment or recent cessation (< 3 mo) of hormone replacement therapy
- •Moderate or severe peripheral artery disease (ankle-brachial index <0.7).
- •A graded exercise test will be performed by all subjects, if there is physician concern or an adverse event, the subject will not participate in a maximal oxygen consumption (VO2max) test (this will be determined in accordance with stated contraindications for exercise testing provided by the American Heart Association).
- •Thyroid disease that is not controlled by medications or <3 month's use of a particular medication and/or dosage (uncontrolled thyroid diseases are associated with alterations in vascular function).
研究组 & 干预措施
MitoQ
Experimental
MitoQ, 20 mg per day for six weeks
干预措施: MitoQ (Drug)
MitoQ
Experimental
MitoQ, 20 mg per day for six weeks
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
Placebo, inert excipient, one time per day for six weeks
干预措施: MitoQ (Drug)
Placebo
Placebo Comparator
Placebo, inert excipient, one time per day for six weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Endothelium-dependent dilation
时间窗: 6 weeks
Flow-mediated dilation
次要结局
- Systemic markers of oxidative stress(6 weeks)
- Motor function(6 weeks)
- Cognitive function(6 weeks)
- Arterial Stiffness(6 weeks)
- Endothelial cell markers of oxidative stress(6 weeks)
研究者
研究点 (1)
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