Water Oxygenation and Brain Activity

Not Applicable

Completed

• Conditions: Muscle Damage
• Interventions: Dietary Supplement: Electrokinetically modified water (EMW); Dietary Supplement: Control Unmodified Placebo Water

• Registration Number: NCT02688452
• Lead Sponsor: NYU Langone Health

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2015-12
• Study First Submitted: 2016-02-03
• Study First Submitted QC: 2016-02-17
• Study First Posted: 2016-02-23
• Status Verified: 2017-07
• Study Completion: 2017-07-01
• Last Update Submitted: 2017-07-12
• Last Update Posted: 2017-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	Electrokinetically modified water (EMW)	Young Healthy Adults
Group 2	Control Unmodified Placebo Water	Young Healthy Adults
Group 1	Control Unmodified Placebo Water	Young Healthy Adults
Group 2	Electrokinetically modified water (EMW)	Young Healthy Adults

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Self reported changes in behavioral state before and after drinking test product	1 Week

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States