Adult SubjectNCT07016191
Effect of Super-Oxygenated Water on Blood Oxygen Saturation
A study testing Ingestion of Water in people with Adult Subject, run by Inhale, Inc at 1 site in United States.
Trial summary
Therapeutic delivery of additional Oxygen to blood stream via hyperbaric and extracorporeal oxygenation that raises blood Oxygen saturation level, apart from oxygenation in the lungs, is known to induce tissue repair, restore normal body functions and improve survival. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adult Subject
- What is being tested?
- Ingestion of Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 28 Nov 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Legally adult (18 years of age or older)
- Subject must be willing to review and provide a written informed consent
- Subject must agree to the study procedures including water ingestion, and SPO2 and heart rate measurements
Who cannot join
- Any active and life-threatening medical condition involving hepatic, renal, cardiac, respiratory, endocrine, or gastrointestinal systems, or any blood disorder in view of the Principal Investigator to confound the study
- Female subjects those are pregnant, nursing or planning to become pregnant
- Subjects receiving any experimental medications or have undergone a major surgical procedure in last 30 days
- Subjects are excluded if they have previously utilized the test article (INHALE superoxygenated water) within the last 24 hours, or have undergone bariatric surgery or have received weight-loss medication
- Subjects with known anemia, hemoglobinopathy or other comorbidity necessitating fluid restriction
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center For Whole Health
Westlake Village, California, 91362
About this study
Official title: A Randomized, Double-blinded and Placebo-controlled Study on Super-Oxygenated Water
Therapeutic delivery of additional Oxygen to blood stream via hyperbaric and extracorporeal oxygenation that raises blood Oxygen saturation level, apart from oxygenation in the lungs, is known to induce tissue repair, restore normal body functions and improve survival. Despite the clinical benefits obtained from these interventions, Oxygen supplementation is rather a medically involved process requiring access to specialized equipment including hyperbaric chambers, cardiac catheterization laboratory and extracorporeal oxygenators, and is not generally amenable for everyday use. The current prospective study will evaluate a non-invasive route for Oxygen delivery through ingestion of super-oxygenated water in adult volunteers. The participants will be randomly assigned to one of the two study groups viz. Inhale super-oxygenated water or placebo control normal water at 1:1 ratio. Neither the participants nor the study doctor will know the treatment assignment. Pre- and post-ingestion measurements will be conducted to evaluate effect of super-oxygenated water.
Read the detailed description
Participants will drink 12 oz of their assigned water (Inhale water or source and taste matched normal water). Baseline blood Oxygen saturation and Heart rate will be measured by a pulse oximeter immediately prior to water ingestion. At one-minute post-ingestion, the blood Oxygen saturation and Heart rate will be measured to compare changes over the baseline. Assessment of Energy level and Brain clarity will be performed as a participant reported outcome measure conducted at pre- and post-ingestion time points through questionnaire.
- Conditions
- Adult Subject
- Being tested
- Ingestion of Water
- Keywords
- Inhale, Super-oxygenated Water, Superoxygenated Water, Blood Oxygen Saturation
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ingestion of WaterOther
Ingestion of Super-Oxygenated or Normal water
| Study group | Role | What they receive |
|---|---|---|
| Inhale Water | Experimental | Participants will ingest 12oz of Inhale Super-Oxygenated water Receives: Other: Ingestion of Water |
| Normal Water | Placebo comparator | Participants will ingest 12oz of Source and Taste-matched normal water Receives: Other: Ingestion of Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2 Response Rate
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.
Measured: From pre-ingestion to post-ingestion of water
Heart Rate Response Rate
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.
Measured: From pre-ingestion to post-ingestion of water
Secondary outcomes (2)
Energy Level Response Rate
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.
Measured: From pre-ingestion to post-ingestion of water
Brain Clarity Response Rate
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.
Measured: From pre-ingestion to post-ingestion of water
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 May 2025
- Primary completion26 Nov 2025
- Study completion28 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adult SubjectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inhale, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deepak Nayak, PhD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016191
- Sponsor's protocol ID
- Inhale-001
- Status last verified
- Jan 2026
- First submitted
- 16 May 2025
- Last updated
- 27 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results will be utilized in business decisions and possible publications. At this point the data may or may not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded and Placebo-controlled Study on Super-Oxygenated Water
- ClinicalTrials.gov ID
- NCT07016191
- Acronym / sponsor ID
- Inhale-001
- Conditions
- Adult Subject
- Keywords
- Inhale, Super-oxygenated Water, Superoxygenated Water, Blood Oxygen Saturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Inhale, IncIndustry (pharma, biotech, devices)
- Study start
- 1 May 2025 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 11 Jun 2025 (actual)
- Results
- Posted 27 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Therapeutic delivery of additional Oxygen to blood stream via hyperbaric and extracorporeal oxygenation that raises blood Oxygen saturation level, apart from oxygenation in the lungs, is known to induce tissue repair, restore normal body functions and improve survival. Despite the clinical benefits obtained from these interventions, Oxygen supplementation is rather a medically involved process requiring access to specialized equipment including hyperbaric chambers, cardiac catheterization laboratory and extracorporeal oxygenators, and is not generally amenable for everyday use. The current prospective study will evaluate a non-invasive route for Oxygen delivery through ingestion of super-oxygenated water in adult volunteers. The participants will be randomly assigned to one of the two study groups viz. Inhale super-oxygenated water or placebo control normal water at 1:1 ratio. Neither the participants nor the study doctor will know the treatment assignment. Pre- and post-ingestion measurements will be conducted to evaluate effect of super-oxygenated water.
Detailed description
Participants will drink 12 oz of their assigned water (Inhale water or source and taste matched normal water). Baseline blood Oxygen saturation and Heart rate will be measured by a pulse oximeter immediately prior to water ingestion. At one-minute post-ingestion, the blood Oxygen saturation and Heart rate will be measured to compare changes over the baseline. Assessment of Energy level and Brain clarity will be performed as a participant reported outcome measure conducted at pre- and post-ingestion time points through questionnaire.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhale Water | Experimental | Other: Ingestion of WaterParticipants will ingest 12oz of Inhale Super-Oxygenated water |
| Normal Water | Placebo comparator | Other: Ingestion of WaterParticipants will ingest 12oz of Source and Taste-matched normal water |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Legally adult (18 years of age or older)
- Subject must be willing to review and provide a written informed consent
- Subject must agree to the study procedures including water ingestion, and SPO2 and heart rate measurements
Key exclusion criteria (5 listed)
- Any active and life-threatening medical condition involving hepatic, renal, cardiac, respiratory, endocrine, or gastrointestinal systems, or any blood disorder in view of the Principal Investigator to confound the study
- Female subjects those are pregnant, nursing or planning to become pregnant
- Subjects receiving any experimental medications or have undergone a major surgical procedure in last 30 days
- Subjects are excluded if they have previously utilized the test article (INHALE superoxygenated water) within the last 24 hours, or have undergone bariatric surgery or have received weight-loss medication
- Subjects with known anemia, hemoglobinopathy or other comorbidity necessitating fluid restriction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ingestion of WaterIngestion of Super-Oxygenated or Normal water | Other | Inhale Water, Normal Water |
Primary outcome
SpO2 Response Rate
Time frame: From pre-ingestion to post-ingestion of water
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.
Heart Rate Response Rate
Time frame: From pre-ingestion to post-ingestion of water
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.
2 secondary outcomes
Energy Level Response Rate
Time frame: From pre-ingestion to post-ingestion of water
Brain Clarity Response Rate
Time frame: From pre-ingestion to post-ingestion of water
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The results will be utilized in business decisions and possible publications. At this point the data may or may not be shared.
Related trials for Adult Subject
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
RecruitingPhase 2
A Study of Cebranopadol for Opioid Withdrawal Symptoms in Adults With Chronic Pain
Chronic Pain, Pain
Recruiting
Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Chronic Study
Healthy Participants, Healthy Adult Subject
Recruiting
Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Acute Postprandial Study
Healthy Participants, Healthy Adult Subject
Not yet recruiting
Photobiomodulation, Heart Rate Variability, and Acute Stress
Stress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepak Nayak, PhD study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ingestion of Water in people with Adult Subject, run by Inhale, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SpO2 Response Rate (time frame: From pre-ingestion to post-ingestion of water). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.