Trial Outcomes & Findings for Effect of Super-Oxygenated Water on Blood Oxygen Saturation (NCT NCT07016191)

Results Overview

Number of participants who experienced an improvement in post-ingestion SpO2. An increase in post-ingestion SpO2 over the pre-ingestion level in the same subject was considered a response.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

From pre-ingestion to post-ingestion of water

Results posted on

2026-01-27

Participant Flow

A total of 60 subjects were enrolled in the study.

The 60 enrolled subjects were randomized into two arms consisting of 30 subjects in each arm.

Participant milestones

Participant milestones
Measure	Inhale Super-Oxygenated Water Participants will ingest one serving of Inhale super-oxygenated water (12 oz).	Placebo Control Participants will ingest one serving of a source and taste-matched normal water (12 oz).
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intent to treat population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inhale Super-Oxygenated Water n=30 Participants Ingestion of Inhale super-oxygenated water	Placebo Control n=30 Participants Ingestion of source and taste-matched normal water as placebo control	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=30 Participants • Intent to treat population	0 Participants n=30 Participants • Intent to treat population	0 Participants n=60 Participants • Intent to treat population
Age, Categorical Between 18 and 65 years	25 Participants n=30 Participants • Intent to treat population	27 Participants n=30 Participants • Intent to treat population	52 Participants n=60 Participants • Intent to treat population
Age, Categorical >=65 years	5 Participants n=30 Participants • Intent to treat population	3 Participants n=30 Participants • Intent to treat population	8 Participants n=60 Participants • Intent to treat population
Age, Continuous	49.5 Year n=30 Participants • Intent to treat population	43.5 Year n=30 Participants • Intent to treat population	47 Year n=60 Participants • Intent to treat population
Sex: Female, Male Female	16 Participants n=30 Participants • Intent to treat population	14 Participants n=30 Participants • Intent to treat population	30 Participants n=60 Participants • Intent to treat population
Sex: Female, Male Male	14 Participants n=30 Participants • Intent to treat population	16 Participants n=30 Participants • Intent to treat population	30 Participants n=60 Participants • Intent to treat population
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	30 participants n=30 Participants • Intent to treat population	30 participants n=30 Participants • Intent to treat population	60 participants n=60 Participants • Intent to treat population

PRIMARY outcome

Timeframe: From pre-ingestion to post-ingestion of water

Population: Intent to treat population

Number of participants who experienced an improvement in post-ingestion SpO2. An increase in post-ingestion SpO2 over the pre-ingestion level in the same subject was considered a response.

Outcome measures

Outcome measures
Measure	Inhale Super-Oxygenated Water n=30 Participants Ingestion of Inhale super-oxygenated water	Placebo Control n=30 Participants Ingestion of source and taste-matched normal water as placebo control
SpO2 Response Rate Positive Response	21 Participants 0.5404	11 Participants 0.3117

PRIMARY outcome

Timeframe: From pre-ingestion to post-ingestion of water

Population: Intent to treat population

Number of participants who experienced a reduction in post-ingestion heart rate. A decrease in post-ingestion heart rate over the pre-ingestion level in the same subject was considered a response.

Outcome measures

Outcome measures
Measure	Inhale Super-Oxygenated Water n=30 Participants Ingestion of Inhale super-oxygenated water	Placebo Control n=30 Participants Ingestion of source and taste-matched normal water as placebo control
Heart Rate Response Rate	21 Participants 2.603	14 Participants 1.347

SECONDARY outcome

Timeframe: From pre-ingestion to post-ingestion of water

Population: Intent to treat population

Number of participants who reported an improvement in post-ingestion energy level. An increase in post-ingestion energy level over the pre-ingestion level in the same subject was considered a response. Energy level was measured by a participant-reported questionnaire titled "Energy Level and Brain Clarity Assessment" with possible scores ranging from 1 (meaning "very-low") through 10 (meaning "very-high") where higher score indicated a greater energy level.

Outcome measures

Outcome measures
Measure	Inhale Super-Oxygenated Water n=30 Participants Ingestion of Inhale super-oxygenated water	Placebo Control n=30 Participants Ingestion of source and taste-matched normal water as placebo control
Energy Level Response Rate	17 Participants 7.520	6 Participants 3.278

SECONDARY outcome

Timeframe: From pre-ingestion to post-ingestion of water

Population: Intent to treat population

Number of participants who reported an improvement in post-ingestion brain clarity. An increase in post-ingestion brain clarity over the pre-ingestion level in the same subject was considered a response. Brain clarity was measured by a participant-reported questionnaire titled "Energy Level and Brain Clarity Assessment" with possible scores ranging from 1 (meaning "very-low") through 10 (meaning "very-high") where higher score indicated a greater brain clarity.

Outcome measures

Outcome measures
Measure	Inhale Super-Oxygenated Water n=30 Participants Ingestion of Inhale super-oxygenated water	Placebo Control n=30 Participants Ingestion of source and taste-matched normal water as placebo control
Brain Clarity Response Rate	15 Participants 3.827	5 Participants 3.519

Adverse Events

Inhale Super-Oxygenated Water

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ian Mitchell

Inhale Inc

Phone: 9185002682

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place