Tokyo, Feb. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060564) titled 'Hydrogen-releasing bath salts for post-exercise recovery (temperature, muscle oxygenation, and oxidative stress): a single-blind crossover pilot study' on Feb. 3.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Placebo
Primary Sponsor:
Institute - Pengyu Deng
Condition:
Condition - Post-exercise fatigue and recovery (recovery with warm-water immersion)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - In healthy young men, whether warm-water immersion with hydrogen-releasing bath salts (Vitalise Bath) differs from warm-water immersion without bath salts (control) during post-exercise recovery, using a single-blind randomized counterbalanced crossover design. We will assess thermoregulation (deep muscle temperature and sublingual temperature), muscle oxygenation (NIRS), and oxidative stress/antioxidant capacity (d-ROMs and BAP). The washout period is 7 days.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - hydrogen-releasing bath salts dissolved
Interventions/Control_2 - warm water
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male
Key inclusion criteria - Healthy males aged from 20 to 29 years
Able to provide written informed consent
Able to attend both sessions (crossover)
Key exclusion criteria - History or current treatment of cardiovascular/respiratory/metabolic diseases
Acute illness/fever, skin disease, or contraindication to hot bathing (e.g., heat intolerance/syncope)
Deemed inappropriate by the investigator
Target Size - 6
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2023 Year 06 Month 16 Day
Date of IRB - 2023 Year 06 Month 16 Day
Anticipated trial start date - 2023 Year 07 Month 25 Day
Last follow-up date - 2023 Year 09 Month 25 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069271
Disclaimer: Curated by HT Syndication.