Water Oxygenation and Brain Activity

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

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).

Study Overview

• Status: Completed
• Conditions: Muscle Damage
• Intervention / Treatment: Dietary supplement: Control Unmodified Placebo Water; Dietary supplement: Electrokinetically modified water (EMW)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; Young Healthy Adults	Dietary supplement: Control Unmodified Placebo Water; Dietary supplement: Electrokinetically modified water (EMW); Other Names: Reliant Recovery Water
Active Comparator: Group 2; Young Healthy Adults	Dietary supplement: Control Unmodified Placebo Water; Dietary supplement: Electrokinetically modified water (EMW); Other Names: Reliant Recovery Water

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Rodolfo Llinás, MD, PhD, New York University Medical School

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: February 3, 2016
• First Submitted That Met QC Criteria: February 17, 2016
• First Posted (Estimate): February 23, 2016

Study Record Updates

• Last Update Posted (Actual): July 13, 2017
• Last Update Submitted That Met QC Criteria: July 12, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: strenuous exercise; muscle soreness
• Other Study ID Numbers: 15-00230