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临床试验/NCT06951789
NCT06951789已完成不适用

Effect of Molecular Hydrogen Inhalation on Metabolic Response in Healthy Females During Low-intensity Exercise on a Bicycle Ergometer: A Randomized, Double-blind, Placebo-controlled Crossover Trial

Palacky University2 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2025年5月5日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Respiratory exchange ratio

研究概览

简要总结

This trial evaluates the effect of molecular hydrogen inhalation on metabolic response, heart rate, and rating of perceived exertion in healthy females during 30 minutes of exercise on a bicycle ergometer.

详细描述

The objective of this randomized, double-blind, placebo-controlled crossover trial is to assess the effect of molecular hydrogen inhalation on metabolic response during 20 min of rest and during exercise on a bicycle ergometer with a workload of 0.5 W/kg for 10 min, 0.75 W/kg for 10 min, and 1 W/kg for 10 min. The trial recruits healthy females aged 20-35 years and the planned sample size is 20. The trial consists of two experimental sessions, one using molecular hydrogen inhalation and the other using placebo inhalation. The washout period between sessions is one week. Randomization of the order of the sessions is performed using a computer random generator. Molecular hydrogen is produced using a hydrogen generator via electrolysis of water and administered through a mouthpiece. Ambient air is used for placebo inhalation. Molecular hydrogen is colorless, odorless, and tasteless, making it indistinguishable from placebo by the human senses. During the session, the following variables are measured: ventilation, oxygen uptake, respiratory exchange ratio, heart rate, rating of perceived exertion, and oxygen saturation. Energy expenditure, fat oxidation rate and carbohydrates oxidation rate are calculated from oxygen uptake and respiratory exchange ratio. Statistical analysis is performed at the 0.05 significance level and data are evaluated using analysis of variance for repeated measures with Fisher's post hoc tests.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Free of major diseases.
  • Signed informed consent.

排除标准

  • Acute conditions contraindicating laboratory testing of exercise.
  • Cardiorespiratory disease.
  • Pharmacotherapy affecting metabolism.
  • Musculoskeletal problems.

研究组 & 干预措施

Molecular hydrogen

Experimental

Molecular hydrogen inhalation for 20 min at rest and 30 min during exercise.

干预措施: Molecular hydrogen (Other)

Placebo

Placebo Comparator

Placebo inhalation for 20 min at rest and 30 min during exercise.

干预措施: Placebo (Other)

结局指标

主要结局

Respiratory exchange ratio

时间窗: Change after 1 week of crossover.

Respiratory exchange ratio is measured with Ergostik analyser (Geratherm Respiratory, Bad Kissinger, Germany) breath by breath during the session and averaged over 5 min windows for subsequent analysis.

次要结局

  • Ventilation(Change after 1 week of crossover.)
  • Oxygen uptake(Change after 1 week of crossover.)
  • Heart rate(Change after 1 week of crossover.)
  • Rating of perceived exertion(Change after 1 week of crossover.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jakub Krejci

Assistant professor

Palacky University

研究点 (2)

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