Effect of Pre-exercise Inhalation of Molecular Hydrogen on Metabolic Response During Graded Exercise in Healthy Women
2026年6月22日 更新者：Jakub Krejci、Palacky University
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
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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
22
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Tereza Rysava
- 電話番号：+420585636154
- メール：tereza.rysava01@upol.cz
研究連絡先のバックアップ
- 名前：Jakub Krejci, PhD
- メール：jakub.krejci@upol.cz
研究場所
-
-
-
Olomouc、チェコ、77111
- 募集
- Palacky University, Faculty of Physical Culture
-
コンタクト：
- Tereza Rysava
- 電話番号：+420585636154
- メール：tereza.rysava01@upol.cz
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- Healthy female participants.
- Regular menstrual cycle with exercise testing scheduled outside the menstrual phase.
- Signed informed consent.
Exclusion Criteria:
- 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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Molecular hydrogen
Molecular hydrogen inhalation for 60 minutes daily for 7 days.
|
Gas mixture containing 3.75% molecular hydrogen and ambient air.
他の名前：
|
|
プラセボコンパレーター：Placebo
Ambient air inhalation for 60 minutes daily for 7 days.
|
Ambient air without molecular hydrogen.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Respiratory exchange ratio
時間枠：Change after 2 weeks of crossover.
|
Respiratory exchange ratio is measured using an Ergostik analyser (Geratherm Respiratory, Bad Kissinger, Germany) breath by breath during the exercise, and the average is calculated for 6-minute segments for subsequent analysis.
|
Change after 2 weeks of crossover.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Oxygen uptake
時間枠：Change after 2 weeks of crossover.
|
Oxygen uptake is measured using an Ergostik analyser (Geratherm Respiratory, Bad Kissinger, Germany) breath by breath during the exercise, and the average is calculated for 6-minute segments for subsequent analysis.
|
Change after 2 weeks of crossover.
|
|
Carbon dioxide production
時間枠：Change after 2 weeks of crossover.
|
Carbon dioxide production is measured using an Ergostik analyser (Geratherm Respiratory, Bad Kissinger, Germany) breath by breath during the exercise, and the average is calculated for 6-minute segments for subsequent analysis.
|
Change after 2 weeks of crossover.
|
|
Minute ventilation
時間枠：Change after 2 weeks of crossover.
|
Minute ventilation is measured using an Ergostik analyser (Geratherm Respiratory, Bad Kissinger, Germany) breath by breath during the exercise, and the average is calculated for 6-minute segments for subsequent analysis.
|
Change after 2 weeks of crossover.
|
|
Breathing frequency
時間枠：Change after 2 weeks of crossover.
|
Breathing frequency is measured using an Ergostik analyser (Geratherm Respiratory, Bad Kissinger, Germany) breath by breath during the exercise, and the average is calculated for 6-minute segments for subsequent analysis.
|
Change after 2 weeks of crossover.
|
|
Heart rate
時間枠：Change after 2 weeks of crossover.
|
Heart rate is continuously recorded during the exercise using a Polar H10 chest strap (Polar, Kempele, Finland), and the average is calculated for 6-minute segments for subsequent analysis.
|
Change after 2 weeks of crossover.
|
|
Blood lactate concentration
時間枠：Change after 2 weeks of crossover.
|
Capillary blood lactate concentration is assessed at baseline (resting condition) and during the final minute of each exercise step using a Lactate Scout device (EKF Diagnostics, Barleben, Germany).
|
Change after 2 weeks of crossover.
|
|
Rating of perceived exertion
時間枠：Change after 2 weeks of crossover.
|
Participants are asked to subjectively rate their perceived exertion at specified time points - at rest and subsequently in the last minute of each exercise step.
The Borg's scale 6-20 is used, where 6 means "no exertion" and 20 means "maximal exertion".
|
Change after 2 weeks of crossover.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Blood glucose concentration
時間枠：Change after 2 weeks of crossover.
|
Capillary blood glucose concentration is assessed at baseline (resting condition) and during the final minute of each exercise step using an Accu-Chek Inform II device (Roche Diagnostics, Manheim, Germany).
|
Change after 2 weeks of crossover.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Tereza Rysava、Palacky University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月22日
一次修了 (推定)
2026年12月1日
研究の完了 (推定)
2026年12月1日
試験登録日
最初に提出
2026年6月8日
QC基準を満たした最初の提出物
2026年6月8日
最初の投稿 (実際)
2026年6月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月25日
QC基準を満たした最後の更新が送信されました
2026年6月22日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
All IPD that underlie results in a publication.
IPD 共有時間枠
Beginning 1 month after the publication of results with no end date.
IPD 共有アクセス基準
Anonymized IPD will be uploaded to an open-access data repository.
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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