Water Oxygenation and Brain Activity

Study Overview
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Brief Summary
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The primary purpose of this interventional, placebo controlled, crossover, double blind, basic science exploratory study is to investigate whether there is a difference in brain electrophysiological oscillatory activity in healthy adults before and after oral consumption of water containing very small bubbles of oxygen (electrokinetically modified water).

Official Title
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Water Oxygenation and Brain Activity: A Magnetoencephalographic (MEG) Pilot Study

Conditions
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Muscle Damage

Intervention / Treatment
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* Dietary Supplement: Control Unmodified Placebo Water
* Dietary Supplement: Electrokinetically modified water (EMW)
* Dietary Supplement: Electrokinetically modified water (EMW)
* Dietary Supplement: Control Unmodified Placebo Water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women of any ethnic background; living in New York tri-state area; fluent in English; normal or corrected to normal vision and hearing; willing to complete all study procedures; and capable of giving written informed consent. Exclusion Criteria: A history of gross brain abnormalities such as stroke, severe ventriculomegaly or severe periventricular white matter abnormalities; a history of serious psychiatric or neurological disorders, including psychosis or major depression, alcohol or drug abuse, brain injury, seizure disorder, brain tumor, etc.; taking psychoactive medications, including antipsychotics, anxiolytics and antidepressants, or cognitive enhancers such as cholinesterase inhibitors; presence of contraindications for MEG or MRI recording, including any of the following: cardiac pacemaker, intracranial clips, metal implants, or external clips within 10 mm of the head, metal in eyes, claustrophobia, obesity and/or any other reason leading to difficulty staying in the MEG or MRI for up to one hour.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Young Healthy Adults | Dietary Supplement: Control Unmodified Placebo Water<br> <br> Dietary Supplement: Electrokinetically modified water (EMW)<br> <br> * Other names: Reliant Recovery Water;|
| Active Comparator: Group 2<br>Young Healthy Adults | Dietary Supplement: Electrokinetically modified water (EMW)<br> <br> Dietary Supplement: Control Unmodified Placebo Water<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in spectral properties measured before and after drinking the test products using Magnetoencephalography (MEG) measurements | Magnetic fields will be recorded using a 275-channel whole-head MEG system | 1 Week | 
| Changes in localization of spontaneous brain activity measured before and after drinking the test products using Magnetoencephalography (MEG) measurements | Magnetic fields will be recorded using a 275-channel whole-head MEG system | 1 Week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self reported changes in behavioral state before and after drinking test product |  | 1 Week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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strenuous exercise, muscle soreness