Effect of Super-Oxygenated Water on Blood Oxygen Saturation

Inhale, Inc

Status: Enrolling

Conditions: Adult Volunteers

Treatments: Other: Ingestion of Water

Study type: Interventional

Funder types: Industry

Identifiers

NCT07016191

Inhale-001

Details and patient eligibility

About

Therapeutic delivery of additional oxygen to blood stream via hyperbaric and extracorporeal oxygenation that raise blood Oxygen saturation level, apart from oxygenation in the lungs, are 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 treatment groups viz. 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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Inhale Water

Experimental group

Description:

Participants will ingest 12oz of Inhale Super-Oxygenated water

Treatment:

Other: Ingestion of Water

Normal Water

Placebo Comparator group

Description:

Participants will ingest 12oz of Source and Taste-matched normal water

Treatment:

Other: Ingestion of Water