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Water Oxygenation and Brain Activity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02688452
Recruitment Status : Completed
First Posted : February 23, 2016
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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).

Condition or disease Intervention/treatment Phase
Muscle Damage Dietary Supplement: Control Unmodified Placebo Water Dietary Supplement: Electrokinetically modified water (EMW) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Water Oxygenation and Brain Activity: A Magnetoencephalographic (MEG) Pilot Study
Study Start Date : December 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : July 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group 1
Young Healthy Adults
 Dietary Supplement: Control Unmodified Placebo Water
Dietary Supplement: Electrokinetically modified water (EMW)
Other Name: Reliant Recovery Water
Active Comparator: Group 2
Young Healthy Adults
 Dietary Supplement: Electrokinetically modified water (EMW)
Dietary Supplement: Control Unmodified Placebo Water


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Self reported changes in behavioral state before and after drinking test product [ Time Frame: 1 Week ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688452


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Rodolfo Llinás, MD, PhD New York University Medical School
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02688452    
Other Study ID Numbers: 15-00230
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Keywords provided by NYU Langone Health:
strenuous exercise
muscle soreness