Adult Subject
Conditions
Keywords
Inhale, Super-oxygenated Water, Superoxygenated Water, Blood Oxygen Saturation
Brief 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. 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.
Interventions
OTHERIngestion of Water
Ingestion of Super-Oxygenated or Normal water
Sponsors
Inhale, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SpO2 Response Rate | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Energy Level Response Rate | From pre-ingestion to post-ingestion of water | 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. |
| Brain Clarity Response Rate | From pre-ingestion to post-ingestion of water | 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. |
Countries
United States
Contacts
STUDY_DIRECTORDeepak Nayak, PhD
Participant flow
Recruitment details
A total of 60 subjects were enrolled in the study.
Pre-assignment details
The 60 enrolled subjects were randomized into two arms consisting of 30 subjects in each arm.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 52 Participants |
| Age, Continuous | 43.5 Year |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
None listed