A Randomized, Double-blinded and Placebo-controlled Study on Super-Oxygenated Water
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- SpO2 Response Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Inhale Water
Participants will ingest 12oz of Inhale Super-Oxygenated water
干预措施: Ingestion of Water (Other)
Normal Water
Participants will ingest 12oz of Source and Taste-matched normal water
干预措施: Ingestion of Water (Other)
结局指标
主要结局
SpO2 Response Rate
时间窗: 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
时间窗: 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.
次要结局
- Energy Level Response Rate(From pre-ingestion to post-ingestion of water)
- Brain Clarity Response Rate(From pre-ingestion to post-ingestion of water)