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Completed

NCT Number: NCT02688452

Water Oxygenation and Brain Activity

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).

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Key information

Conditions

Muscle Damage Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control Unmodified Placebo Water

Dietary Supplement

Electrokinetically modified water (EMW)

Dietary Supplement

Other names: Reliant Recovery Water

Primary outcomes

  1. Changes in spectral properties measured before and after drinking the test products using Magnetoencephalography (MEG) measurements

    Time frame: 1 Week

    Magnetic fields will be recorded using a 275-channel whole-head MEG system

  2. Changes in localization of spontaneous brain activity measured before and after drinking the test products using Magnetoencephalography (MEG) measurements

    Time frame: 1 Week

    Magnetic fields will be recorded using a 275-channel whole-head MEG system

Secondary outcomes

  1. Self reported changes in behavioral state before and after drinking test product

    Time frame: 1 Week

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2017
First posted
Feb 23, 2016
Registry last updated
Jul 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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