Effect of Super-Oxygenated Water on Blood Oxygen Saturation

NCT07016191 | Completed Results

• 1 other identifier: Inhale-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Subject

Keywords

Inhale; Super-oxygenated Water; Superoxygenated Water; Blood Oxygen Saturation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Energy Level Response Rate

  From pre-ingestion to post-ingestion of water

• Brain Clarity Response Rate

  From pre-ingestion to post-ingestion of water

Study Arms (2)

Inhale Water

EXPERIMENTAL

Participants will ingest 12oz of Inhale Super-Oxygenated water

Other: Ingestion of Water

Normal Water

PLACEBO COMPARATOR

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

Other: Ingestion of Water

Interventions

Ingestion of Water OTHER

Ingestion of Super-Oxygenated or Normal water

Inhale Water; Normal Water

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inhale, Inc: lead

Study Sites (1)

The Center For Whole Health

Westlake Village, California, 91362, United States

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ian Mitchell
• Organization: Inhale Inc

ianmitchell81@gmail.com

9185002682

Study Officials

• Deepak Nayak, PhD

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: June 11, 2025
• Study Start: May 1, 2025
• Primary Completion: November 26, 2025
• Study Completion: November 28, 2025
• Last Updated: January 27, 2026
• Results First Posted: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)