Water Oxygenation and Brain Activity

Muscle Damage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02688452
• Other study ID #: 15-00230
• Status: Completed
• Phase: N/A
• First received: February 3, 2016
• Last updated: July 12, 2017
• Start date: December 2012
• Est. completion date: July 1, 2017

Study information

• Verified date: July 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 1, 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Damage

Intervention

Dietary Supplement:
• Control Unmodified Placebo Water

• Electrokinetically modified water (EMW)

• Electrokinetically modified water (EMW)

• Control Unmodified Placebo Water

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Self reported changes in behavioral state before and after drinking test product		1 Week