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Идёт набор NCT06480695

Exercise Training Intensity and Nitrate Supplementation in Post-Menopausal Females

Без фазы С лечением Menopause

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Nitrate-Rich Beetroot Juice, High Intensity Exercise, Moderate Intensity Exercise, Nitrate-Depleted Placebo Beetroot Juice.
Кому может быть актуально
Состояния в реестре: Menopause. Базовые параметры: 45 лет — 75 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Effects of Exercise Training Intensity and Inorganic Nitrate Supplementation on Vascular Health and Fitness in Post-Menopausal Females

Обзор

Menopause greatly increases cardiovascular disease risk (CVD). Current exercise guidelines are inadequate to ameliorate this risk and higher intensity exercise may be necessary for cardiovascular benefits in postmenopausal females. Oral nitrate supplementation enhances exercise performance and CVD risk profile in several clinical conditions. The investigators recently reported that 3-days of nitrate supplementation in postmenopausal females enhances acute post-exercise vascular function, in an intensity dependent manner. The effects of nitrate supplementation and exercise training over a longer training program remains unexplored. This investigation will examine the impact of exercise training intensity with and without inorganic nitrate supplementation, on CVD and fitness outcomes. Postmenopausal females will be tested for maximal oxygen uptake and lactate threshold before randomization to one of four groups: that inorganic nitrate-rich beetroot juice, or beetroot juice with nitrate extracted; and assigned to one-month of calorie matched high-intensity or moderate-intensity exercise training. Vascular function and fitness will be evaluated before and after training.

Вмешательства

  • Пищевая добавка Nitrate-Rich Beetroot Juice
    subjects will consume 1 bottle of nitrate-rich beetroot juice (\~400mg of nitrate each) 2x a day
  • Поведенческое High Intensity Exercise
    exercise at an intensity midway between the lactate threshold and VO2peak, from the screening test at an RPE of \~ 15-17
  • Поведенческое Moderate Intensity Exercise
    exercise at the RPE at LT associated an \~ RPE of 10-12
  • Пищевая добавка Nitrate-Depleted Placebo Beetroot Juice
    Subjects will consume 1 bottle of nitrate-depleted beetroot juice 2x a day

Первичные конечные точки

  • Vascular Endothelial Function (Flow-Mediated Dilation [FMD]) [Срок оценки: Baseline and after 1-month of exercise training]
  • Cardiorespiratory Fitness [Срок оценки: Baseline and after 1-month of exercise training]
Вторичные конечные точки (9)
  • Oral Nitrate Reducing Capacity [Срок оценки: Baseline and after 1-month of exercise training]
  • Skeletal muscle perfusion [Срок оценки: Baseline and after 1-month of exercise training]
  • Peripheral and Central Blood Pressures [Срок оценки: Baseline and after 1-month of exercise training]
  • 24-hour ambulatory blood pressure [Срок оценки: Baseline and after 1-month of exercise training]
  • Skeletal muscle microvascular perfusion (near-infra-red- spectroscopy) [Срок оценки: Baseline and after 1-month of exercise training]
  • Lipids [Срок оценки: Baseline]
  • Hemoglobin [Срок оценки: Baseline and after 1-month of exercise training]
  • Plasma Nitrate [Срок оценки: Baseline and after 1-month of exercise training]
  • Plasma Nitrite [Срок оценки: Baseline and after 1-month of exercise training]

Критерии участия

Критерии включения

  • Post-menopausal female (greater than age 45 but less than age 75)
  • Sedentary (does not exercise regularly or less than 2 bouts of exercise per week)
  • No major changes in medication in the last 3 months

Критерии исключения

  • Smokers within last 5 years
  • Weight unstable (loss/gain of more than 3kg in the past 3 months)
  • Any medical condition that prevents the subject from exercising safely
  • Hormone replacement therapy (current or within last 3 months)
  • Diabetes
  • Currently or recently on vasoactive medications (i.e., calcium channel blockers, statins, ACE or renin inhibitors, ARBs, nitrates, alpha- or beta-blockers, diuretics, proton pump inhibitors, etc.)
  • Oral antibiotic use within previous four weeks
  • Oral disease or poor oral health as determined by the Oral Health Questionnaire
  • Using an antibacterial mouthwash or a mouthwash containing chlorhexidine and unwilling to discontinue use

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • Student Health and Wellness Building - Department of Kinesiology — Charlottesville

Идентификаторы

NCT: NCT06480695 · HSR231665

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗