Clinical Trial: An exploratory interventional study on the association between hydrogen nanobubble water intake and exercise performance indices during a cycling exercise task (Japan)

Tokyo, July 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062352) titled 'A study on cycling exercise performance and perceived fatigue after drinking hydrogen nanobubble water' on July 28.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Single blind -participants are blinded Control - Placebo

Primary Sponsor: Institute - R Professional University Of Rehabilitation

Condition: Condition - Healthy adults (no specific disease targeted) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To explore, in healthy adults, the association between hydrogen nanobubble water (HNW) intake and exercise performance indices (such as distance covered) and subjective burden during a 20-minute cycling exercise task, by comparing an HNW condition with an ordinary drinking water condition in a randomized crossover design. Participants are blinded to the allocated beverage condition (single blind). No invasive examinations such as blood sampling are performed. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Hydrogen nanobubble water (HNW) condition: On the measurement day, participants ingest a total of 500 mL of hydrogen nanobubble water (Hydrogen NanoGAS Water, Symbiosis Co., Ltd.). Of this, 250 mL is ingested before the start of the cycling task, and the remaining 250 mL is ingested during the 5-minute warm-up and over the first 10 minutes of the 20-minute main cycling task. The beverage is dispensed into identical unlabeled containers identified only by container number, so that participants are not informed of the beverage condition on that measurement day. Volume, temperature, and container are matched to the ordinary drinking water condition. Time of ingestion, volume ingested, and any change in physical condition after ingestion are recorded. The intervention is a single-dose administration on one measurement day, with a 3-7 day interval between this condition and the ordinary drinking water condition. Interventions/Control_2 - Ordinary drinking water condition (control): On the measurement day, participants ingest a total of 500 mL of ordinary drinking water. Volume, timing, temperature, and container are identical to the HNW condition; the beverage is dispensed into identical unlabeled containers identified only by container number. Time of ingestion, volume ingested, and any change in physical condition after ingestion are recorded. The intervention is a single-dose administration on one measurement day, with a 3-7 day interval from the HNW condition.

Exercise task common to both conditions: Using a cycle ergometer (POWER MAX V3 CONNECT, Konami Sports Co., Ltd.), participants perform a 5-minute warm-up at a workload of 1 kp, followed by 20 minutes of cycling at a workload set in kp using body weight (kg) x 0.035 as a guide. Participants are instructed to continue exercising within the range they themselves judge sustainable for 20 minutes; forced continuation is not required. A 5-minute cool-down at low workload follows. Participants refrain from high-intensity exercise for 24-48 hours before measurement and from food intake for 3 hours before measurement; caffeine intake is also matched between conditions as far as possible.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - Participants must meet all of the following 1. Students or faculty/staff enrolled at R Professional University of Rehabilitation 2. Aged 18 years or older and under 65 years 3. Able to understand the study and provide written informed consent of their own free will 4. Judged able to safely perform the cycling exercise task 5. Able to comply with the pre-measurement standardization (avoiding high-intensity exercise for 24-48 hours before measurement, fasting for 3 hours before measurement, etc.) and to attend two measurement sessions separated by 3-7 days Key exclusion criteria - Participants meeting any of the following are excluded 1. Those judged unable to safely perform the cycling exercise task due to cardiovascular, respiratory, or orthopedic disease 2. Those judged, by self-report or prior confirmation, as possibly having symptoms aggravated by exercise 3. Those under exercise restriction by a physician 4. Those with poor physical condition on the measurement day (fever, marked fatigue, dizziness, nausea, chest discomfort, etc.) 5. Those with difficulty understanding the study procedures 6. Those judged by the principal investigator to be unsuitable for participation for any other reason Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 10 Day Date of IRB - 2026 Year 07 Month 07 Day Anticipated trial start date - 2026 Year 07 Month 28 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071359

Disclaimer: Curated by HT Syndication.