Effect of Pre-exercise Inhalation of Molecular Hydrogen on Metabolic Response During Graded Exercise in Healthy Women
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: Molecular hydrogen, Placebo.
- Кому может быть актуально
- Состояния в реестре: Healthy Adult Females. Базовые параметры: 18 лет — 30 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
- Чехия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Effect of Repeated Pre-exercise Inhalation of Molecular Hydrogen on Metabolic Response During Graded Exercise in Healthy Women: A Randomized, Double-blind, Placebo-controlled Crossover Trial
Обзор
The goal of this clinical trial is to evaluate if molecular hydrogen can reduce the metabolic response during graded exercise in healthy women aged 18-30 years. The main questions it aims to answer are: * Does molecular hydrogen reduce the respiratory exchange ratio? * Does molecular hydrogen reduce oxygen uptake? Researchers will compare molecular hydrogen to a placebo (ambient air containing no molecular hydrogen) to see if molecular hydrogen reduces the metabolic response. Participants will: * Inhale molecular hydrogen for 60 minutes each day for 7 days. * Undergo an exercise testing twice after a two-week washout period.
Подробное описание
This crossover trial examines the effect of repeated inhalation of molecular hydrogen on the metabolic response during graded exercise in healthy female participants. Each participant undergoes two experimental interventions (molecular hydrogen and placebo) in random order, separated by a two-week washout period. The order of the interventions is randomized using a computer random number generator. Each intervention consists of 7 days, during which participants inhale either molecular hydrogen or placebo gas for 60 minutes daily under resting conditions. Molecular hydrogen is produced by electrolysis of water and mixed with ambient air in the chamber to achieve a hydrogen concentration of 3.75 % which is below the lower explosive limit. This gas is administered via a face mask connected to an Ambu bag system with a one-way valve to ensure standardized delivery. Placebo is produced by pumping ambient air without molecular hydrogen. Molecular hydrogen is colorless, odorless, and tasteless, making it indistinguishable from placebo by human senses. On the 7th day of each intervention, participants undergo a graded exercise test on an bicycle ergometer immediately following the final inhalation session. The protocol consists of 8 incremental steps with the workload increasing from 0.5 to 2.25 W/kg. Outcome measures collected at rest before exercise and during exercise include cardiorespiratory variables, capillary blood biomarkers, and perceived exertion. Statistical analysis is based on a two-way analysis of variance for repeated measures, and p \< 0.05 is considered statistically significant.
Вмешательства
- Другое Molecular hydrogen
Gas mixture containing 3.75% molecular hydrogen and ambient air. - Другое Placebo
Ambient air without molecular hydrogen.
Первичные конечные точки
- Respiratory exchange ratio [Срок оценки: Change after 2 weeks of crossover.]
Вторичные конечные точки (7)
- Oxygen uptake [Срок оценки: Change after 2 weeks of crossover.]
- Carbon dioxide production [Срок оценки: Change after 2 weeks of crossover.]
- Minute ventilation [Срок оценки: Change after 2 weeks of crossover.]
- Breathing frequency [Срок оценки: Change after 2 weeks of crossover.]
- Heart rate [Срок оценки: Change after 2 weeks of crossover.]
- Blood lactate concentration [Срок оценки: Change after 2 weeks of crossover.]
- Rating of perceived exertion [Срок оценки: Change after 2 weeks of crossover.]
Критерии участия
Критерии включения
- Healthy female participants.
- Regular menstrual cycle with exercise testing scheduled outside the menstrual phase.
- Signed informed consent.
Критерии исключения
- Pregnancy or breastfeeding.
- History or presence of cardiovascular disease.
- History or presence of respiratory disease.
- Regular use of medications affecting metabolism.
- Use of dietary supplements affecting metabolism within 14 days prior to intervention.
- Strenuous physical activity within 24 hours prior to exercise testing.
- Any contraindication to exercise testing or study participation determined by a physician.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Двойное слепое
- Основная цель
- Фундаментальное исследование
Центры проведения
Чехия · 1 центр
- Palacky University, Faculty of Physical Culture — Olomouc
Идентификаторы
NCT: NCT07644000 · FTK_2026_14