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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhale Water | Experimental | Participants will ingest 12oz of Inhale Super-Oxygenated water |
|
| Normal Water | Placebo Comparator | Participants will ingest 12oz of Source and Taste-matched normal water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ingestion of Water | Other | Ingestion of Super-Oxygenated or Normal water |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From pre-ingestion to post-ingestion of water |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deepak Nayak, PhD | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center For Whole Health | Westlake Village | California | 91362 | United States |
The results will be utilized in business decisions and possible publications. At this point the data may or may not be shared.
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The 60 enrolled subjects were randomized into two arms consisting of 30 subjects in each arm.
A total of 60 subjects were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Inhale Super-Oxygenated Water | Participants will ingest one serving of Inhale super-oxygenated water (12 oz). |
| FG001 | Placebo Control | Participants will ingest one serving of a source and taste-matched normal water (12 oz). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All consented study subjects were included in the analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Inhale Super-Oxygenated Water | Ingestion of Inhale super-oxygenated water |
| BG001 | Placebo Control | Ingestion of source and taste-matched normal water as placebo control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Participants who are eligible and provide informed consent |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent to treat population | Posted | Count of Participants | Participants | From pre-ingestion to post-ingestion of water |
|
Adverse events were monitored from time of consent through post-ingestion time point.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inhale Super-Oxygenated Water | Ingestion of Inhale super-oxygenated water | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ian Mitchell | Inhale Inc | 9185002682 | ianmitchell81@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 16, 2025 | Jan 8, 2026 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 20, 2025 | Jan 8, 2026 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 12, 2025 | Jan 8, 2026 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. | From pre-ingestion to post-ingestion of water |
| BG002 | Total | Total of all reporting groups |
Intent to treat population
| Count of Participants |
| Participants |
|
| Age, Continuous | Participants who are eligible and provide informed consent | Intent to treat population | Median | Inter-Quartile Range | Year |
|
| Sex: Female, Male | Participants who are eligible and provide informed consent | Intent to treat population | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Subjects were recruited from the United States America | Intent to treat population | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | 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. | Intent to treat population | Posted | Count of Participants | Participants | From pre-ingestion to post-ingestion of water |
|
|
|
|
| Secondary | 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. | Intent to treat population | Posted | Count of Participants | Participants | From pre-ingestion to post-ingestion of water |
|
|
|
|
| Secondary | 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. | Intent to treat population | Posted | Count of Participants | Participants | From pre-ingestion to post-ingestion of water |
|
|
|
|
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Placebo Control | Ingestion of source and taste-matched normal water as placebo control | 0 | 30 | 0 | 30 | 0 | 30 |
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