Effect of Super-Oxygenated Water on Blood Oxygen Saturation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2025-11-28

Brief Summary

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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.

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Detailed Description

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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

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Adult Subject

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Inhale Water

Participants will ingest 12oz of Inhale Super-Oxygenated water

Group Type EXPERIMENTAL

Ingestion of Water

Intervention Type OTHER

Ingestion of Super-Oxygenated or Normal water

Normal Water

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

Group Type PLACEBO_COMPARATOR

Ingestion of Water

Intervention Type OTHER

Ingestion of Super-Oxygenated or Normal water

Interventions

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Ingestion of Water

Ingestion of Super-Oxygenated or Normal water

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes