Oral Antioxidant Therapy Targeted to the Mitochondria for Improving Brain Artery Health in Postmenopausal Women

Официальное название

Mitochondrial-Targeted Antioxidant Supplementation for Improving Cerebrovascular Function in Postmenopausal Women

Обзор

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

Вмешательства

• Пищевая добавка Mitoquinone (MitoQ)
  MitoQ is a biochemically modified form of ubiquinol Other Names: Mitoquinol
• Пищевая добавка Placebo
  Each placebo capsule contains inert excipient and is identical in appearance

Первичные конечные точки

• Change from baseline in cerebrovascular conductance at 3 months [Срок оценки: 3 months]

Вторичные конечные точки (9)

• Change from baseline in cerebrovascular reactivity at 3 months [Срок оценки: 3 months]
• Change from baseline in mitochondrial oxidative stress-mediated suppression of cerebrovascular conductance at 3 months [Срок оценки: 3 months]
• Change from baseline in mitochondrial oxidative stress-mediated suppression of cerebrovascular reactivity at 3 months [Срок оценки: 3 months]
• Change from baseline in internal carotid artery dilation in response to hypercapnia at 3 months [Срок оценки: 3 months]
• Change from baseline in mitochondrial oxidative stress-mediated suppression of internal carotid artery dilation at 3 months [Срок оценки: 3 months]
• Change from baseline in total cerebral blood flow at 3 months [Срок оценки: 3 months]
• Change from baseline in cerebrovascular stiffness at 3 months [Срок оценки: 3 months]
• Change from baseline in carotid artery compliance at 3 months [Срок оценки: 3 months]
• Change from baseline in mitochondrial oxidative stress-mediated suppression of carotid artery compliance at 3 months [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Translational Physiology Laboratory within the Food Science Clinical Research Laboratory — Fort Collins

Идентификаторы

NCT: NCT07406243 · 7559 · K01HL177339

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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